An article from

Maria Rachal

[email protected]

Maria joined MedTech Dive as an associate editor in 2018. A D.C. area native, she holds a bachelor's degree in journalism and politics from Washington and Lee University and formerly covered politics and science news for media outlets in the U.S. and Australia.

268 articles by Maria Rachal

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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 to propose 1-year MDR delay
March 25, 2020
CDRH lays out filing extensions, shift from in-person amid coronavirus response
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 still paused
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 to acquire Hitachi's diagnostic imaging arm for $1.63B
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
West Virginia AG sues J&J, Ethicon over mesh marketing
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

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