Maria Rachal

337 articles by Maria Rachal

• Insulet tops Q2 forecasts, as diabetes tech resilient in wake of coronavirus

  Aug. 7, 2020

• NuVasive's spine robot sees delay, again

  Aug. 5, 2020

• Zimmer sees COVID-19 backlog worth up to $800M, aims to double Rosa robot volume by year's end

  Aug. 4, 2020

• Device maker Q2 reports show optimism on COVID-19 recovery, but flare-ups keep guidance at bay

  Aug. 3, 2020

• Varian sold to Siemens Healthineers in $16.4B all-cash deal

  Aug. 2, 2020

• Stryker sales slump 24% on elective surgery hits, but Mako robot demand a 'pleasant surprise'

  July 31, 2020

• Dexcom nixes plan to begin G7 launch this year

  July 29, 2020

• Boston Scientific sees sharp US recovery in Q2, CEO says 'procedures can't be deferred forever'

  July 29, 2020

• Medtechs reboot with patients, providers after elective surgeries bottom out

  July 27, 2020

• How COVID-19 is challenging and changing medtech supply chain management

  July 27, 2020

• Boston Scientific to begin limited US launch of latest Watchman device

  July 22, 2020

• Quest coronavirus test becomes 1st with FDA OK for sample pooling

  July 20, 2020

• Ambu wins FDA clearance for single-use duodenoscope product

  July 17, 2020

• Thermo Fisher ups Qiagen offer by 10% after investor backlash cites COVID-19 growth

  July 16, 2020

• BD sells 750K antigen tests to HHS as COVID-19 nursing home testing scales up

  July 15, 2020

• Medtronic to buy out Medicrea, seeking spinal surgery boost

  July 15, 2020

• Abbott lays out plan for US study of FreeStyle Libre 3

  July 13, 2020

• Quest Q2 better than feared, as demand surges for COVID-19 diagnostics

  July 13, 2020

• FDA plans to restart domestic inspections, contingent on local coronavirus trends

  July 10, 2020

• Intersect ENT stock jumps on report of potential Medtronic takeover

  July 8, 2020

• CMS not yet sold on Baxter, Outset tech in kidney care payment proposal

  July 8, 2020

• Labs, ASCs get slice of $521B in COVID-19 paycheck protection loans

  July 8, 2020

• Endologix files for Ch. 11 bankruptcy, plans to go private

  July 6, 2020

• OTC hearing aid proposal, EtO sterilizer rule make 2020 regulatory agenda

  July 2, 2020

• UnitedHealthcare adds coverage of Tandem insulin pumps

  July 1, 2020

• Q&A: New NESTcc chief on the real-world evidence group's 'pivot point' and COVID-19

  June 29, 2020

• Texas again halts elective surgeries, showing fragile nature of rebound

  June 26, 2020

• Payer coverage of employer, surveillance COVID-19 tests not required, feds say

  June 25, 2020

• FDA signals support for automated insulin dosing tech, backing new development tool

  June 25, 2020

• Invitae scoops up ArcherDX in $1.4B precision oncology deal

  June 22, 2020

• Pandemic pushes FDA to 'accelerate' real-world evidence efforts, Hahn says

  June 19, 2020

• Tandem's insulin dosing algorithm OK'd for use in younger kids

  June 17, 2020

• In FDA 1st, game-based therapeutic gets marketing OK

  June 16, 2020

• Abbott's FreeStyle Libre 2 gets long-awaited iCGM nod from FDA

  June 15, 2020

• Key data on Medtronic's 780G, Insulet's Horizon kick off ADA 2020

  June 12, 2020

• Surgeons, device makers grow more confident in elective care comeback

  June 11, 2020

• Surmodics gets CE mark for Abbott-backed paclitaxel-coated balloon

  June 8, 2020

• Insulet's pivotal study back on track, setting up Horizon launch in early 2021

  June 5, 2020

• PMA major deficiency letters tick up, 510(k) asks for info flatline: MDUFA report

  June 4, 2020

• How 3 smaller medtechs are navigating COVID-19

  June 1, 2020

• At-home COVID-19 test kits set to climb as Quest, LetsGetChecked get FDA nods

  May 29, 2020

• EU group sets path for pre-MDR notified body renewal, coronavirus-era surveillance

  May 28, 2020

• Medtechs eye key role of ASCs in return of elective care

  May 26, 2020

• Martha plots M&A, Hugo robot sees delay: Takeaways from Medtronic's Q4

  May 22, 2020

• Investors bet diabetes tech immune to full brunt of COVID-19

  May 19, 2020

• Allergan's breast implant postmarket studies 'unacceptable,' FDA warns

  May 15, 2020

• Consumer COVID-19 fears, coverage concerns could stymie medtech rebound: Wall Street surveys

  May 14, 2020

• Abiomed faces familiar reimbursement fluctuation in CMS proposal

  May 12, 2020

• Zimmer posts $509M loss in Q1 as 80% of business faces COVID-19 hit

  May 11, 2020

• Roundup: Q1 medtech reports give glimpse into coronavirus-era gains and losses

  May 7, 2020

• Respiratory muscle stimulator greenlighted by FDA for COVID-19 patients

  May 4, 2020

• Stryker sees 50% of revenue vulnerable to elective procedure pullback

  May 1, 2020

• Abiomed buys artificial lung device for use with Impella, potential COVID-19 patients

  April 30, 2020

• Boston Scientific sees April sales cut in half amid coronavirus

  April 29, 2020

• Dexcom's hospital strategy accelerates, but next-gen iCGM path slows

  April 29, 2020

• Digital therapeutic makers see opportunity as pandemic prompts FDA to ease rules

  April 24, 2020

• It's official: EU finalizes 1-year MDR delay

  April 24, 2020

• FDA OKs updated instructions for Abbott POC coronavirus test amid accuracy concerns

  April 23, 2020

• Medtronic sees US business fall 60% amid pandemic response

  April 22, 2020

• FDA device review times could get iffy, agency chief says

  April 17, 2020

• Abbott enters coronavirus antibody testing fray

  April 15, 2020

• GE, Medtronic, ResMed among 7 medtechs part of $1.4B in finalized HHS ventilator contracts

  April 14, 2020

• FDA authorizes 1st coronavirus test using at-home collection of saliva samples

  April 14, 2020

• Medtechs adapt to new sales reality amid halt on elective surgeries, hospitals' financial stress

  April 9, 2020

• HHS, CVS, Walgreens get behind Abbott's coronavirus test

  April 8, 2020

• FDA authorizes Cellex coronavirus antibodies test

  April 3, 2020

• Medtechs navigate new normal as FDA shifts priorities to coronavirus

  April 3, 2020

• OrthoPediatrics buys FDA-approved scoliosis tech, challenging Zimmer for market

  April 2, 2020

• Abbott touts speed, scale of POC coronavirus test

  March 30, 2020

• In Pre-Cert 1st, FDA clears app-based treatment for chronic insomnia

  March 27, 2020

• Small PAMA victory in aid package, but labs remain in 'untenable situation'

  March 26, 2020

• EU regulators propose 1-year MDR delay

  March 25, 2020

• CDRH pushes out response due date extensions, teleconference policy by at least a month

  March 24, 2020

• Medtronic pledges '24/7' ventilator production to meet coronavirus demand

  March 19, 2020

• Lessons from Hurricane Maria could aid Baxter's coronavirus operations

  March 18, 2020

• Intuitive Surgical among 1st big medtechs to warn of costly pandemic disruptions

  March 17, 2020

• Hospitals advised to rethink elective procedures, potentially straining device makers

  March 16, 2020

• Thermo Fisher coronavirus test gets FDA nod

  March 15, 2020

• Roche is 1st commercial coronavirus test maker to win FDA emergency use authorization

  March 13, 2020

• TransMedics to get FDA expert review for heart transplant device PMA

  March 12, 2020

• Key EU notified body meeting goes on, virtually

  March 11, 2020

• ECRI: Poor sterilization, failure to learn from device problems threaten patient safety

  March 10, 2020

• ACC 2020 meeting canceled as coronavirus spreads in US

  March 9, 2020

• LabCorp launches coronavirus test, Quest in the wings

  March 5, 2020

• FDA bans certain electrical stimulation devices called 'barbaric'

  March 4, 2020

• After waffling, Qiagen agrees to $11.5B buyout by Thermo Fisher

  March 3, 2020

• Insulet pauses automated dosing system trial amid software glitch

  March 2, 2020

• LivaNova loops Verily into depression device study

  Feb. 27, 2020

• Wright Medical misses Q4 targets as Cartiva shortfall persists

  Feb. 26, 2020

• Tandem shapes FDA strategy for new insulin pump features

  Feb. 25, 2020

• FDA taps breakthrough device meant to prevent opioid overdose deaths

  Feb. 24, 2020

• 1st test for genetic condition tied to developmental delay wins FDA nod

  Feb. 24, 2020

• Dexcom makes inroad in pregnant population with CE mark for CGM

  Feb. 21, 2020

• Abbott, Dexcom outline plans for CGM compatibility with Insulet's Horizon

  Feb. 19, 2020

• Medtronic misses revenue estimates as TAVR position falters

  Feb. 18, 2020

• AdvaMed, state AGs weigh in ahead of EPA sterilization rule

  Feb. 14, 2020

• Dexcom hopes wave of new customers offsets lower prices, Abbott's sweet spot

  Feb. 14, 2020

• Medtronic buys British surgical AI company, adding to Hugo robot effort

  Feb. 13, 2020

• Insulet warns of defect with Dash personal diabetes manager

  Feb. 13, 2020

• Medtronic insulin pump recall tied to 1 death, more than 2K injuries, FDA says

  Feb. 12, 2020

• Intuitive buys IT startup for surgical video sharing, archiving, analysis

  Feb. 11, 2020

• FDA OKs 1st AI tool to help non-specialists take cardiac ultrasounds

  Feb. 10, 2020

• FDA puts high-risk label on GE Healthcare anesthesia systems recall

  Feb. 10, 2020

• Snapshot: How medtech earnings season is shaping up

  Feb. 7, 2020

• BD cuts 2020 guidance on Alaris pump hangup with FDA, stock tanks

  Feb. 6, 2020

• Boston Scientific expects up to $40M hit in Q1 from coronavirus

  Feb. 5, 2020

• Emergency use coronavirus tests shows glitches at state level, CDC says

  Feb. 4, 2020

• Abbott wins breakthrough tag for fully implantable LVAD system, following Medtronic

  Feb. 4, 2020

• Zimmer's Rosa robot drives Q4 growth, restructuring set

  Feb. 4, 2020

• Amid coronavirus outbreak, FDA and industry seek roadmap for emergency diagnostics

  Jan. 31, 2020

• J&J hit with $344M verdict in California pelvic mesh trial

  Jan. 31, 2020

• Abbott wins 1st EU approval for transcatheter mitral valve replacement device

  Jan. 30, 2020

• 5-year Edwards results: TAVR matches surgery on survival, but repeat hospitalizations more common

  Jan. 30, 2020

• Robot sales spike to new high as Stryker eyes growth in Japan

  Jan. 29, 2020

• CMS widens NGS test coverage for inherited breast, ovarian cancers

  Jan. 28, 2020

• After subdued year for new spinal cord stim tech, industry seeks 2020 rebound

  Jan. 27, 2020

• FDA offers 510(k) advice for arthroscopy pump tubing to prevent cross-patient infections

  Jan. 27, 2020

• Smith & Nephew acquires Tusker's PMA-winning ear infection device for ENT portfolio

  Jan. 24, 2020

• Intuitive eyes new surgery types as competitive pressure looms

  Jan. 24, 2020

• Abbott ups 2020 growth targets, downplays Libre 2 delay

  Jan. 22, 2020

• Medline's Illinois sterilization plant comes back online

  Jan. 21, 2020

• 5 medtech trends to track in 2020

  Jan. 17, 2020

• Dexcom talks up Type 2 market, Medtronic says it has 'work to do' in diabetes at JPM

  Jan. 16, 2020

• Medtronic at JPM: More tuck-ins under Martha and key trial results ahead

  Jan. 14, 2020

• Nevro, NuVasive, Integra, others preview earnings at JPM

  Jan. 13, 2020

• Medtronic buys new spinal cord tech to boost pain therapies unit

  Jan. 9, 2020

• Abbott sets CFO transition in motion

  Jan. 8, 2020

• Medtronic warns of Mazor X detachment issue in robotic surgery

  Jan. 7, 2020

• Industry, doctors, patients diverge on FDA outline for breast implant labels

  Jan. 6, 2020

• FTC slaps Stryker, Wright Medical with second request

  Jan. 2, 2020

• Roundup 2019: Breast implants, mesh, paclitaxel-coated devices among hot topics at FDA expert panels

  Dec. 23, 2019

• Wright Medical filings, report hint of rivals to Stryker's $5.4B acquisition

  Dec. 20, 2019

• J&J takes over Verb Surgical as Verily exits robotics partnership

  Dec. 20, 2019

• Fujifilm announces delay to $1.63B buyout of Hitachi's diagnostic imaging arm

  Dec. 19, 2019

• Medtronic acquires meal detection tech to bolster personalized closed loop system

  Dec. 18, 2019

• J&J vision vet named B. Braun Medical CEO

  Dec. 17, 2019

• Tandem wins FDA go-ahead for 1st interoperable, automated insulin dosing software

  Dec. 16, 2019

• Dekra Netherlands notified body gains EU MDR designation

  Dec. 16, 2019

• FDA greenlights first newborn screening test aid for Duchenne muscular dystrophy

  Dec. 12, 2019

• Sunlight doesn't dent industry funding to doctors over half-decade

  Dec. 12, 2019

• Dexcom app outage highlights communication pitfalls for device makers

  Dec. 10, 2019

• Rivalry of the Year: Abbott and Dexcom's race to dominate CGM

  Dec. 9, 2019

• Executive of the Year: Kevin Lobo, Stryker

  Dec. 9, 2019

• Analysts cool expectations for Edwards' mitral performance

  Dec. 6, 2019

• Edwards projects up to $5B in 2020 sales

  Dec. 5, 2019

• Baxter closes $350M acquisition of Sanofi's Seprafilm adhesion barrier

  Dec. 2, 2019

• Roundup: How major medtechs fared in Q3

  Nov. 27, 2019

• FDA approves J&J spinout's device for kids with recurring ear infections

  Nov. 26, 2019

• 5 insights into Dexcom's year ahead from CEO Kevin Sayer

  Nov. 25, 2019

• LivaNova to shutter mitral valve replacement line

  Nov. 20, 2019

• Incoming Medtronic CEO to prioritize 'aggressive' tuck-in M&A, 'reinvigorating' diabetes unit

  Nov. 19, 2019

• In stents v. statin debate, analysts call potential impact of ISCHEMIA trial overhyped

  Nov. 18, 2019

• FDA advisers: Metal implants need beefed up ingredient labels

  Nov. 15, 2019

• FDA experts weigh evidence on patients' adverse reactions to common device metals

  Nov. 13, 2019

• Establishment Labs sees 40% rise in breast implant sales, on track for $100M benchmark in 2020

  Nov. 12, 2019

• Exact Sciences closes Genomic Health deal, wins breakthrough tag for liver cancer blood test

  Nov. 8, 2019

• Dexcom posts 53% US revenue growth in 'blowout' Q3

  Nov. 7, 2019

• Europe allows Edwards' Sapien 3 TAVR system in low-risk patients

  Nov. 6, 2019

• Tandem awaits FDA's Control-IQ nod, Insulet puts finishing touches on Horizon

  Nov. 6, 2019

• 2 more notified bodies win EU MDR nod, bumping industry tally to 7

  Nov. 5, 2019

• Hips and knees help Zimmer beat Wall Street amid growing Stryker rivalry

  Nov. 5, 2019

• Stryker goes to extrem(iti)es in $4B Wright Medical takeout

  Nov. 4, 2019

• Trump picks MD Anderson's Stephen Hahn for FDA chief

  Nov. 1, 2019

• Google to acquire Fitbit in $2.1B deal, challenging Apple

  Nov. 1, 2019

• Abiomed targets 'TAVR-like' adoption for protected PCI

  Oct. 31, 2019

• Mako momentum lifts Stryker results amid core spine drag

  Oct. 30, 2019

• A UK challenger to da Vinci seeks to chip away at robotic surgery 'monopoly'

  Oct. 28, 2019

• BD to suspend sterilization plant after FDA warning on device shortages

  Oct. 25, 2019

• FDA clears duodenoscope add-on device aimed at reducing infection

  Oct. 25, 2019

• Baxter accounting investigation clouds Q3 results

  Oct. 24, 2019

• TAVR vet in at Medtronic diabetes unit amid shakeup

  Oct. 21, 2019

• Leasing da Vinci systems is in style: Intuitive Q3 tops estimates

  Oct. 18, 2019

• CMR launches robot, CEO says European deals coming soon

  Oct. 16, 2019

• J&J device business outperforms in China as US pricing pressures persist

  Oct. 15, 2019

• Abbott deepens Type 2 diabetes play with Omada partnership

  Oct. 14, 2019

• Edwards-backed Corvia gets leg up with FDA breakthrough nod

  Oct. 10, 2019

• Tariff headwinds still hurting Philips' connected care margins, execs warn

  Oct. 10, 2019

• Medtronic stent graft system wins breakthrough designation

  Oct. 8, 2019

• Medtech investor duo seeks to 'fill the gap' in device sector private funding

  Oct. 8, 2019

• Intersect ENT misses endpoint on chronic sinusitis DCB, sending shares down

  Oct. 7, 2019

• Paclitaxel device makers roll out revised labels, fresh safety analyses

  Oct. 3, 2019

• FDA designates AI software meant to boost ultrasound accessibility a breakthrough device

  Oct. 1, 2019

• Implanted metal devices, dental amalgam to go under FDA's microscope

  Sept. 30, 2019

• Australia enforces new regs on all breast implant makers, suspends some devices

  Sept. 27, 2019

• BD picks new CEO

  Sept. 26, 2019

• Medtechs keep shareholders happy, potentially at pipeline's expense: EY

  Sept. 23, 2019

• FDA lowers Cologuard age to 45, adding 19M to Exact's screening market

  Sept. 23, 2019

• Zimmer Biomet dental unit to distribute Invisalign maker's intraoral scanners

  Sept. 20, 2019

• J&J settles with West Virginia over allegations on mesh, hips

  Sept. 19, 2019

• Mesh as good as hysterectomy for prolapse, 3-year NIH data suggests

  Sept. 18, 2019

• Sanofi taps Abbott, Novo adds Medtronic for CGM integrations

  Sept. 16, 2019

• FDA awards breakthrough designation to nerve regeneration tech

  Sept. 12, 2019

• US needs cyber-savvy doctors as connected device use rises, FDA panel says

  Sept. 11, 2019

• FDA looks to define 'triggers' for medical device cybersecurity warnings

  Sept. 10, 2019

• Axonics wins PMA for sacral neuromod system, challenging Medtronic

  Sept. 9, 2019

• Livongo posts 'good enough' first earnings since IPO, but stock tanks

  Sept. 5, 2019

• With partner iRhythm, Verily ramps up AFib efforts

  Sept. 5, 2019

• Stryker spends up to $500M to boost spine unit with imaging, robotics tech

  Sept. 4, 2019

• Weight-loss surgery for Type 2 diabetes could cut major heart risks, study suggests

  Sept. 3, 2019

• Summer slowdown drags on for De Novos

  Aug. 30, 2019

• Medtronic's Ishrak set to retire after nearly decade as CEO

  Aug. 28, 2019

• Abbott touts potential of 15-minute concussion detection

  Aug. 27, 2019

• Breast implant makers vie for customers amid Allergan recall

  Aug. 26, 2019

• FDA flags recall of Edwards TAVR delivery system tied to 1 death, 17 injuries

  Aug. 22, 2019

• ViewRay touts promising early results from localized prostate cancer trial after disappointing quarter

  Aug. 21, 2019

• Medtronic to ramp up TAVR, robotics programs after Street-beating Q1

  Aug. 20, 2019

• Boston Scientific closes acquisition of BTG

  Aug. 19, 2019

• Edwards, Medtronic win expanded indications for low-risk TAVR patients

  Aug. 16, 2019

• Tidepool CEO talks Pre-Cert era, interoperability

  Aug. 16, 2019

• FDA taps Type A aortic dissection stent for breakthrough program

  Aug. 15, 2019

• AFib device maker AtriCure to spend up to $300M in SentreHeart buyout

  Aug. 12, 2019

• Insulin pump makers post double digit gains amid record patient additions

  Aug. 6, 2019

• CMS eases breakthrough device path to reimbursement in final rule

  Aug. 5, 2019

• Abiomed investors spooked by drop in heart pump adoption

  Aug. 2, 2019

• Hill-Rom picks up wearable ventilator maker in $130M deal

  Aug. 2, 2019

• Dexcom CGM adoption booms as it looks to 'aggressively' pursue Type 2 market

  Aug. 1, 2019

• CMS pitches add-on payment for new renal care tech, DME fee adjustments

  July 30, 2019

• Exact Sciences to gain breast, prostate cancer tests in $2.8B deal

  July 29, 2019

• Zimmer Biomet to increase robotics R&D as new CFO takes helm

  July 26, 2019

• Baxter predicts pouring $500M into US renal care expansion

  July 25, 2019

• Asia, structural heart central to Boston Scientific's second half strategy

  July 24, 2019

• Medtronic to distribute AI stroke detection and triage software

  July 22, 2019

• Intuitive sees bump to Q2 leasing revenues

  July 19, 2019

• Breast reconstruction device manufacturer files for bankruptcy

  July 18, 2019

• Abbott teases FreeStyle Libre potential beyond glucose monitoring

  July 17, 2019

• J&J pegs new robotic surgery platforms, cementless knees as device growth drivers

  July 16, 2019

• Philips, DHS flag cyber vulnerability in EKG analysis software

  July 15, 2019

• Pediatric device approval numbers are slowly rising, but not necessarily for young kids

  July 12, 2019

• Australia seeks ban on Allergan textured breast implants, J&J and others on thin ice

  July 12, 2019

• Baxter to expand home dialysis on heels of Trump kidney initiative

  July 11, 2019

• The 10 biggest medtech stories of Q2

  July 9, 2019

• UnitedHealth backs Inspire Medical's sleep apnea implant

  July 9, 2019

• Varian, Boston Scientific seal the deal on beads business transfer

  July 2, 2019

• Health tech IPO activity picks up with filings from Livongo, Health Catalyst, Phreesia

  June 28, 2019

• FDA language on breast density info sharing inadequate, some mammography stakeholders say

  June 28, 2019

• Boston Scientific touts potential of BTG buy, structural heart strategy

  June 27, 2019

• Yale researchers predict 3D mammography to become standard of care

  June 24, 2019

• FDA safety panel to weigh paclitaxel-coated stents, balloons

  June 18, 2019

• Margin for error 'almost zero' in testing pediatric devices

  June 14, 2019

• Device interoperability, CGM for Type 2 patients among ADA 2019 standouts

  June 10, 2019

• Apple Watch's newest health addition: menstrual cycle tracking

  June 4, 2019

• UK regulators discourage use of paclitaxel devices to treat intermittent claudication

  June 4, 2019

• FDA, industry, advisers say surgical staplers warrant premarket review

  May 31, 2019

• FDA consults surgical device experts on down-classing certain hemostatic agents

  May 31, 2019

• Health Canada makes it official: Macrotextured breast implants off the market

  May 29, 2019

• FDA experts meet to mull up-classing surgical staplers

  May 29, 2019

• Test kit to speed diagnosis of joint replacement infections wins De Novo

  May 24, 2019

• Medtronic posts flat Q4, but beats Wall Street expectations

  May 23, 2019

• Edwards presents 6-month data on Pascal, eyeing MitraClip

  May 23, 2019

• Varian ups presence in India with $283M acquisition

  May 21, 2019

• Real-world operations: NESTcc director on building a business and the future of device evaluation

  May 20, 2019

• FDA calls Essure postmarket study progress 'adequate' in adverse event update

  May 16, 2019

• Grail's multi-cancer blood test nabs breakthrough device status

  May 14, 2019

• Bound for 3M, KCI gets De Novo for negative pressure device

  May 10, 2019

• Medtronic finalizes Titan Spine deal

  May 10, 2019

• Boston Scientific closes acquisition of spinal device in $465M deal

  May 9, 2019

• Aiming to boost transplant availability, FDA advises on organ preservation devices

  May 8, 2019

• Allergan breast implant sales drop more than 30% in Q1

  May 7, 2019

• Diabetes tech companies share beat-and-raise start to 2019

  May 6, 2019

• FDA ends summary reporting, says it will not ban any breast implants

  May 3, 2019

• Hologic posts another 'tale of two cities' quarter, analysts say

  May 2, 2019

• 3M completes $6.7B takeout of Acelity

  May 2, 2019

• FDA cautions against off-label use of Stryker's Wingspan stent system

  April 26, 2019

• Boston Scientific Q1 hit by woes over mesh, paclitaxel, sterilization

  April 24, 2019

• FDA advisory panels set for surgical staplers, paclitaxel devices

  April 23, 2019

• FDA clears first medical device indicated for ADHD

  April 22, 2019

• FDA orders Boston Scientific, Coloplast to pull transvaginal mesh from market

  April 17, 2019

• J&J device revenue slumps amid big bet on digital surgery

  April 16, 2019

• CMS support software mandate for imaging decisions backed by MIT study

  April 12, 2019

• FDA sounds alarm on unregulated brain injury devices

  April 11, 2019

• Australia stops short of breast implant ban

  April 10, 2019

• Pharmas see potential in digital therapeutics, but payers still on the fence: Rock Health

  April 9, 2019

• Canada, France take hard action on textured breast implants

  April 5, 2019

• New TAVR analysis adds to CMS volume-outcomes debate

  April 4, 2019

• Cryotherapy spray for COPD gets FDA breakthrough boost

  April 4, 2019

• Q1'19 digital health investments slow, but IPOs brewing

  April 2, 2019

• Bigfoot CEO talks data-driven diabetes care and becoming a service company

  April 1, 2019

• Smith & Nephew picks up pressure injury prevention device

  April 1, 2019

• FDA seeks to step up mammography oversight, info sharing

  March 28, 2019

• FDA's Day 2 of breast implant panel mulls: Who should lead on informed consent?

  March 27, 2019

• FDA experts weigh 'man-made' cancer linked to breast implants

  March 26, 2019

• With imperfect data, FDA turns to panel for way forward on breast implants

  March 22, 2019

• FDA takes hard look at breast implant safety amid fresh cancer fears

  March 21, 2019

• JDRF-backed Korean medtech gets breakthrough nod for closed loop system

  March 18, 2019

• Apple, Medtronic and more medtech to track at ACC19

  March 14, 2019

• Stryker to spend up to $220M on rotator cuff tear tech

  March 14, 2019

• NCI Director Ned Sharpless to be named FDA acting commissioner

  March 12, 2019

• NCI Director Ned Sharpless to be FDA acting commissioner

  March 12, 2019

• 23andMe to gauge Type 2 diabetes risk

  March 11, 2019

• FDA advisers weigh in on HPV screens

  March 7, 2019

• What does Gottlieb's resignation mean for medtech?

  March 6, 2019

• As robotic surgery booms, FDA cautions against use for cancer

  March 1, 2019

• Medtronic ablation offerings heat up with Accurian launch

  Feb. 27, 2019

• Insulet, Tandem ride wave of diabetes tech

  Feb. 26, 2019

• Biotronik's drug-eluting stent expands to US market with PMA

  Feb. 25, 2019

• Improper inhaler use common among majority of asthmatics: study

  Feb. 22, 2019

• Abbott and Novo Nordisk plan to link diabetes devices

  Feb. 21, 2019

• Boston Scientific-BTG deal faces FTC holdup

  Feb. 15, 2019

• New medtech initiatives to be funded amid 9% FDA budget boost

  Feb. 15, 2019

• FDA panel backs vaginal mesh option, wants more data

  Feb. 13, 2019

• Boston Scientific, Coloplast transvaginal meshes in spotlight at FDA panel

  Feb. 8, 2019

• Breast implant-associated lymphoma tied to at least nine US deaths, FDA says

  Feb. 7, 2019

• Boston Scientific targets structural heart, international market growth in 2019

  Feb. 6, 2019

• CMS eases study parameters in depression device coverage decision

  Feb. 5, 2019

• FDA sets neurology, microbiology device panel meetings for March

  Jan. 31, 2019

• Thermo Fisher posts 16% yearly sales growth, 7% specialty diagnostics bump

  Jan. 30, 2019

• Gottlieb, Shuren tout 2018 as 'record' year for novel devices

  Jan. 29, 2019

• Boston Scientific rolls out latest DBS systems targeting Parkinson's

  Jan. 25, 2019

• J&J hit with $120M bill in 46-state hip implant marketing settlement

  Jan. 23, 2019

• Hereditary colorectal cancer screen is 23andMe's latest FDA nod

  Jan. 23, 2019

• J&J posts $27B in 2018 medical device sales in slight bump

  Jan. 22, 2019

• J&J to study Apple Watch with heart health app

  Jan. 18, 2019

• NIH, Fitbit launch real-world data collection effort

  Jan. 17, 2019

• Medtech therapeutic areas to track in 2019

  Jan. 15, 2019

• Edwards Lifesciences pays Boston Scientific $180M to settle multiple patent disputes

  Jan. 15, 2019

• Boston Scientific, Medtronic give glimpse into 2019 at JPM

  Jan. 9, 2019

• Boston Scientific reports $9.82B in 2018 sales

  Jan. 8, 2019

• Mayo Clinic: Cervical cancer screenings less common than reported

  Jan. 7, 2019

• Concussion diagnostic tech on rise with FDA clearances

  Jan. 3, 2019

• Regulatory makeovers and international game changers: MedTech Dive's top stories of 2018

  Dec. 22, 2018

• FDA-cleared, wearable blood pressure device hits market

  Dec. 21, 2018

• BD gets 510(k) for viral gastroenteritis diagnostic

  Dec. 21, 2018

• FDA pitches shorter grace period for UDI revision

  Dec. 20, 2018

• Medtronic launches spinal surgery system with Mazor technology

  Dec. 19, 2018

• Smith & Nephew completes meniscus repair acquisition

  Dec. 19, 2018

• FDA: Benefits beat risks with unregulated medical software

  Dec. 14, 2018

• Boston Scientific scores US victory in TAVR patents battle

  Dec. 12, 2018

• Pear's digital treatment for opioid abuse gets FDA nod

  Dec. 11, 2018

• AdvaMed, MITA offer feedback on CDRH guidance priorities

  Dec. 7, 2018

• FDA seeks to boost use of De Novo pathway with proposed rule

  Dec. 5, 2018

• Medtronic subsidiary to pay $17.9M in DOJ settlement

  Dec. 5, 2018

• 8 medtech companies get leg up from FDA for opioid devices

  Dec. 4, 2018

• FDA offers more study options for CLIA waivers in redrafted guidances

  Nov. 30, 2018

• Patient perspective missing in device clinical trials, FDA says

  Nov. 27, 2018

• CMS gives mixed ruling on LivaNova depression device

  Nov. 21, 2018

• Abbott seeks clearer security standards as feds increase cyber risk focus

  Nov. 16, 2018

• Millennial to menopausal, women's health is fertile space for startups

  Nov. 14, 2018