202 articles by Elise Reuter

• Zimmer Biomet Q4 net loss widens on supply problems; CEO targets acquisitions

  Feb. 3, 2023

• Friday Q&A: Medtronic’s Chan talks patient monitoring spinoff, rise of home care

  Feb. 2, 2023

• Stryker expects 2023 growth despite 15% dip in Q4 net income

  Feb. 1, 2023

• LivaNova recalls circulatory support device for software fix

  Jan. 30, 2023

• Friday Q&A: Tandem’s chief strategy officer talks tubeless pumps, Type 2 plans

  Jan. 27, 2023

• Abbott sees ‘signs of stability’ for 2023 as hospital staffing, supply chain improves

  Jan. 25, 2023

• Medtronic asks HVAD users to return batteries with welding defects

  Jan. 23, 2023

• Diabetes outlook: What Dexcom, Medtronic and other leaders are watching in 2023

  Jan. 20, 2023

• Dexcom CEO discusses 2023 plans, expanding to more patients with Type 2 diabetes

  Jan. 19, 2023

• Bayer to buy AI imaging platform Blackford Analysis to bolster radiology growth strategy

  Jan. 18, 2023

• Medtech companies start 2023 on ‘optimistic’ note amid earnings forecasts, staffing: J.P. Morgan

  Jan. 17, 2023

• Olympus gets two FDA warning letters over safety of reprocessed endoscopes

  Jan. 12, 2023

• Intuitive forecasts 12%-16% growth in procedures in 2023 even as da Vinci robot sales slowed in Q4

  Jan. 11, 2023

• How Abbott plans to make its Freestyle Libre a $10B product

  Jan. 10, 2023

• ResMed responds to ‘humanitarian emergency’ over demand for CPAP devices with new factory

  Jan. 10, 2023

• Medtronic CEO Martha: No more divestitures planned for 2023, but review continues

  Jan. 9, 2023

• Dexcom forecasts 2023 revenue to rise as much as 20% on G7 launch

  Jan. 9, 2023

• Baxter to spin off renal care, acute therapies units

  Jan. 6, 2023

• Zimmer to acquire soft tissue repair firm Embody for as much as $275M

  Jan. 5, 2023

• GE HealthCare starts trading on Nasdaq as independent company

  Jan. 4, 2023

• A look back at medtech’s top 10 acquisitions of 2022

  Dec. 22, 2022

• J&J closes acquisition of heart pump maker Abiomed

  Dec. 22, 2022

• Freenome CEO Mike Nolan talks colorectal cancer test, clinical trials

  Dec. 22, 2022

• Philips’ studies argue recalled DreamStation CPAP machines unlikely to harm patients’ health

  Dec. 21, 2022

• Diagnostic testing reform missing from Congress’ year-end spending bill

  Dec. 21, 2022

• Fraud risk increased among Medicare DME suppliers who enrolled under pandemic waivers: GAO

  Dec. 19, 2022

• Pfizer to partner with Mayo Clinic spinoff on early cardiac amyloidosis detection

  Dec. 16, 2022

• Siemens, GE Healthcare are interested in Medtronic spinoff units: Bloomberg

  Dec. 15, 2022

• Illumina defends Grail acquisition before FTC amid potential divestiture order in Europe

  Dec. 15, 2022

• Dexcom’s Jake Leach discusses preparations for G7 launch next year

  Dec. 15, 2022

• Healthcare groups urge Congress to pass diagnostic testing reform before year’s end

  Dec. 13, 2022

• Apple locked in court battles with small medtech firms over allegations of stolen technology

  Dec. 13, 2022

• Dexcom’s G7 glucose monitor wins awaited FDA clearance

  Dec. 8, 2022

• Edwards CEO Mussallem to retire, Bernard Zovighian named successor

  Dec. 8, 2022

• Abiomed’s Impella RP heart pump finds use limited after FDA review of critically ill patients

  Dec. 6, 2022

• Medtronic’s HVAD system recalled again amid driveline cover problems

  Dec. 1, 2022

• GE’s board finalizes healthcare spinoff

  Dec. 1, 2022

• Boston Scientific to buy Apollo Endosurgery for $615M as entry into endobariatric market

  Nov. 29, 2022

• Teleflex launches another round of restructuring

  Nov. 23, 2022

• Philips respirator recall reaches 260 reported deaths, FDA says

  Nov. 22, 2022

• Medtronic lowers full-year forecast, citing drop in procedure growth

  Nov. 22, 2022

• Friday Q&A: Embecta CEO talks BD spinoff, future of diabetes devices

  Nov. 18, 2022

• Medtronic’s renal denervation treatment ‘still a viable therapy’ despite study miss, doctors say

  Nov. 17, 2022

• Exact Sciences founders raise $56M for new liquid biopsy venture

  Nov. 17, 2022

• How Labcorp, Abbott, BD, Siemens plan to expand home testing market

  Nov. 16, 2022

• Pear Therapeutics undergoes another round of layoffs, cutting 22% of staff

  Nov. 15, 2022

• Friday Q&A: GE HealthCare’s Shetty on building accurate AI tools

  Nov. 11, 2022

• BD says inflationary pressures persist; COVID-19 test sales plunge

  Nov. 10, 2022

• Medtronic misses primary endpoint in renal denervation study

  Nov. 8, 2022

• 5 takeaways from the FDA’s list of AI-enabled medical devices

  Nov. 7, 2022

• Insulet reports record number of new customers on Omnipod 5 launch; shares climb

  Nov. 4, 2022

• Quest broadens access to COVID-19 multiplex tests as flu cases rise

  Nov. 3, 2022

• J&J to buy heart device maker Abiomed for $16.6B in year’s largest medtech deal

  Nov. 1, 2022

• Thermo Fisher will buy The Binding Site for $2.6B to gain specialty diagnostics portfolio

  Oct. 31, 2022

• Dexcom Q3 profit surges as CGM maker prepares for G7 launch in U.S.

  Oct. 28, 2022

• Baxter lowers 2022 earnings forecast, citing supply chain, foreign-exchange pressures

  Oct. 27, 2022

• Medtech M&A decline poised to continue in 2023 amid ‘bumpy’ market: report

  Oct. 26, 2022

• Boston Scientific exceeds Q3 revenue growth forecast on heart devices; profit sinks on R&D costs

  Oct. 26, 2022

• GE HealthCare revenue rose 6% in Q3 as supply chain woes ease

  Oct. 25, 2022

• Medtronic’s planned spinoff ‘doesn’t move the needle’ in growth strategy: analysts

  Oct. 24, 2022

• Medtronic will spin out slower-growth patient monitoring, respiratory units to focus on core businesses

  Oct. 24, 2022

• Testing overhaul faces a ‘narrow pathway’ to pass before year end, industry groups say

  Oct. 20, 2022

• Abbott Q3 device sales slowed by supply chain pressures; COVID-19 tests exceed expectations

  Oct. 19, 2022

• J&J touts rising procedure volumes, lowers full-year forecast on foreign-exchange concerns

  Oct. 18, 2022

• Insulet flags battery problem with Omnipod DASH system

  Oct. 17, 2022

• Medtronic’s faulty HVAD controllers get an emergency-only software fix

  Oct. 17, 2022

• Friday Q&A: BD’s Broache talks women’s health, at-home testing

  Oct. 14, 2022

• GE shores up contrast supply through deal with Chilean miner

  Oct. 13, 2022

• Jiangsu Well Biotech distributed unapproved COVID-19 tests, FDA says

  Oct. 12, 2022

• Software to predict risk of sepsis, stroke should be regulated as a medical device, says FDA

  Oct. 11, 2022

• Friday Q&A: Paige CEO Andy Moye on how digital pathology is changing the diagnostic game

  Oct. 7, 2022

• Quest agrees to buy Ohio-based health system’s lab-testing business

  Oct. 6, 2022

• Medtech companies shift strategy as more orthopedic procedures move to ambulatory surgical centers

  Oct. 5, 2022

• Roche Diagnostics taps new CEO

  Oct. 4, 2022

• Illumina looks to resolve Grail acquisition ‘sooner rather than later’: analysts

  Oct. 4, 2022

• Medtech groups praise MDUFA passage as legislators plan to include reforms in end-of-year bill

  Oct. 3, 2022

• Congress passes continuing resolution reauthorizing FDA user fees; bill heads to Biden for signature

  Sept. 29, 2022

• Teleflex completes acquisition of Standard Bariatrics amid slow year for medtech M&A

  Sept. 29, 2022

• Bionic pancreas led to lower blood sugar levels than standard of care: study

  Sept. 29, 2022

• B. Braun acquires suite of catheter securement products from Starboard medical for undisclosed amount

  Sept. 28, 2022

• FDA user fees package won’t include any amendments, House leaders say

  Sept. 27, 2022

• Hospital procedures have remained steady since H2 in boost for medtechs, survey finds

  Sept. 26, 2022

• Friday Q&A: Scripps’ Jay Pandit talks about wearables, decentralized trials and what’s next for digital health

  Sept. 22, 2022

• FDA user fee package to be included in Congress’ bill to fund government, avoid shutdown, Senators say

  Sept. 22, 2022

• As deadline for FDA user fees bill nears, Congress weighs continuing resolution

  Sept. 22, 2022

• Watchdog faults FDA for rushing COVID-19 tests to market by easing emergency use rules

  Sept. 21, 2022

• Zimmer Biomet gets FDA clearance for Identity shoulder system

  Sept. 20, 2022

• Edwards gets FDA nod for mitral regurgitation treatment

  Sept. 16, 2022

• Edwards head of TAVR, Larry Wood, says more urgency needed in treating heart valve disease

  Sept. 16, 2022

• FDA eases authorization policy for monkeypox tests as lab group points to ‘lessons learned’ from Covid-19

  Sept. 15, 2022

• Medtronic reports two deaths related to endotracheal tube recall

  Sept. 14, 2022

• Medtronic signs development deal with surgical robot-maker Titan Medical

  Sept. 12, 2022

• Philips says French prosecutors investigating respirator recall

  Sept. 9, 2022

• Friday Q&A: BD Life Sciences President Dave Hickey shares plans for expanded testing ‘menu’

  Sept. 8, 2022

• French prosecutors investigating Philips Respironics recall: Reuters

  Sept. 8, 2022

• FDA issues first EUA for monkeypox test

  Sept. 8, 2022

• Illumina’s hold on Grail depends now on separate appeals in US, Europe

  Sept. 6, 2022

• Medtronic recalls endotracheal tubes after reports of airway obstruction

  Sept. 2, 2022

• Judge rules in favor of Illumina-Grail merger, countering FTC concerns

  Sept. 1, 2022

• Another COVID-19 test supplier ordered by FDA to take its products off the market

  Sept. 1, 2022

• Dispute over monkeypox test reimbursement rates may hurt effort to halt disease’s spread: experts

  Aug. 31, 2022

• Invacare drops CEO, changes board amid broader restructuring

  Aug. 31, 2022

• Philips settles government claim for $4.2M over military certification of portable patient monitors

  Aug. 31, 2022

• Abbott HeartMate 3 LVAD shows improved survival rate compared to older heart pump

  Aug. 29, 2022

• Medtronic’s extravascular ICD meets safety, efficacy endpoints in recent study

  Aug. 29, 2022

• Akili CEO Martucci sees ‘massive’ need for company’s ADHD video-game treatment

  Aug. 29, 2022

• Medtronic reports six more injuries, one additional death related to HVAD battery problems

  Aug. 26, 2022

• Integra pulls intracranial pressure monitors for inaccurate readings

  Aug. 24, 2022

• Philips respirator lawsuit builds as plaintiffs’ attorneys outline lengthy recall delays

  Aug. 23, 2022

• Medtronic CEO says supply chain starting to stabilize as sales dropped, profits rose in Q1

  Aug. 23, 2022

• Teleflex will buy Standard Bariatrics for $170M to gain Titan stapler

  Aug. 22, 2022

• Akili raises $163M in ‘blank-check’ merger, plans to commercialize digital treatment for ADHD

  Aug. 22, 2022

• Laser vision correction procedures fell 16% in the second quarter

  Aug. 22, 2022

• Edwards gets CE mark for Pascal Precision system, allowing device to be marketed in Europe

  Aug. 19, 2022

• Eargo plans to sell its hearing aids in stores after over-the-counter ruling

  Aug. 18, 2022

• New entrants may shake up hearing-aid market after FDA clears path for OTC sales

  Aug. 17, 2022

• Hearing aids to be available over the counter following final FDA rule

  Aug. 16, 2022

• J&J, other orthopedics companies faced unequal pandemic recovery in second quarter

  Aug. 15, 2022

• Pear Therapeutics trims workforce, forecast as state contracts move slower than expected

  Aug. 12, 2022

• ‘Underfunded’ FDA falls short in ensuring medical devices protect against cyberattacks, experts say

  Aug. 11, 2022

• As monkeypox cases increase, disease experts lament lack of testing access

  Aug. 10, 2022

• Friday Q&A: FDA’s former medical device cybersecurity director says more investment needed in staffing

  Aug. 5, 2022

• 6 questions for the medtech industry if Congress doesn’t reauthorize FDA user fees on time

  Aug. 3, 2022

• Zimmer Biomet raises revenue forecast on faster-than-expected COVID recovery

  Aug. 2, 2022

• Illumina vows to fight EU efforts to block $8B Grail merger

  Aug. 1, 2022

• Insulet moves to full launch of Omnipod 5

  Aug. 1, 2022

• Edwards TAVR unit weighed down by hospital staffing shortages

  July 29, 2022

• Medtech industry applauds as Senate passes $280B measure to bolster U.S. chip production

  July 27, 2022

• Stryker boosts sales forecast, sees steady demand from hospitals

  July 27, 2022

• 3M to spin out its healthcare business

  July 26, 2022

• Pear Therapeutics restructures, looks to slash development costs

  July 26, 2022

• Philips and U.S. Justice Dept. in consent decree talks on sleep apnea, ventilator recall

  July 25, 2022

• Philips shares hit 10-year low as supply chain challenges weigh on revenue

  July 25, 2022

• FDA to expand use of remote regulatory assessments beyond the pandemic

  July 25, 2022

• Johns Hopkins sepsis alert tool reduced patient deaths, studies find

  July 22, 2022

• Friday Q&A: Matthew Binnicker, Mayo Clinic's director of clinical virology, talks COVID-19, monkeypox testing

  July 22, 2022

• AbbVie agrees to pay $60M for rights to acquire implantable glaucoma device

  July 20, 2022

• FDA patient advisers grapple with consent, oversight of virtual-reality devices in healthcare

  July 20, 2022

• J&J lowers full-year sales forecast amid rising inflation, currency pressures

  July 19, 2022

• FDA faces furloughs if Senate misses August deadline for user fee bill

  July 15, 2022

• Friday Q&A: Ian Lipkin, Columbia epidemiologist, talks COVID-19 testing as U.S. sees another wave

  July 15, 2022

• With medtech shares down 30%, investors worry about inflation, staffing shortages: William Blair

  July 14, 2022

• With COVID testing on the wane, small diagnostics companies shift focus

  July 13, 2022

• Faulty oximeter readings led to racial, ethnic disparities in treatment: study

  July 12, 2022

• SD Biosensor agrees to buy Meridian Bioscience for $1.53B in bid to enter U.S. IVD market

  July 7, 2022

• Senators press FDA to finalize OTC hearing aids, accuse industry of 'astroturf' campaigns

  July 6, 2022

• COVID-19 antigen test sensitivity could be as low as 60% with omicron: FDA

  July 5, 2022

• Friday Q&A: Canary Medical CEO Bill Hunter discusses knee-implant sensors, device reimbursement

  July 1, 2022

• Commercial labs to ramp up monkeypox testing in 'coming weeks'

  June 29, 2022

• Eargo reaches financing deal as it looks to regain insurance coverage after DOJ settlement

  June 29, 2022

• Companies see a future for smart implants. Doctors are waiting for proof.

  June 28, 2022

• User fee package goes to Senate with lab-developed test, OTC hearing aid provisions

  June 15, 2022

• House passes FDA user-fee package, bolstering cybersecurity, clinical trial diversity for medical devices

  June 9, 2022

• BD to acquire Parata for $1.53B as part of strategy to boost margins

  June 7, 2022

• FDA to start accepting all pre-submissions for in vitro diagnostics

  June 1, 2022

• Medtronic expects supply chain issues to continue after 'catastrophic explosion' last quarter

  May 26, 2022

• Proposed LDT regulations has diagnostics industry, consumer groups at odds

  May 25, 2022

• FDA user-fee bill goes to House; Senate committee draft revamps diagnostic regulations

  May 19, 2022

• Pear more than doubles revenue from last quarter, shares new economic data

  May 17, 2022

• Earnings week 4: Vicarious expects 2024 FDA filing for surgical robot; Steris reports record backlogs

  May 16, 2022

• House subcommittee debates device remanufacturing definition, sends user-fees bill to next stage

  May 12, 2022

• Roundup: As procedures rebound, supply chain, staffing challenges set to continue for medtechs

  May 11, 2022

• House user-fees bill details clinical trial diversity, cybersecurity requirements

  May 10, 2022

• Ortho revenue rebounds in Q1 even amid 'tough' start, labor shortages

  May 5, 2022

• CDRH proposes requirement for Philips to submit recall plan for sleep-apnea, ventilator devices

  May 3, 2022

• Earnings week 2: Supply chain shortages slowed ResMed, other medtechs from meeting demand

  May 2, 2022

• GE Healthcare, Medtronic turn to outpatient care in new partnership

  April 29, 2022

• Edwards sees boost in TAVR volumes; CEO says hospitals 'still recovering' from the pandemic

  April 27, 2022

• Intuitive sees double-digit procedure growth, warns of slowing hospital placements

  April 22, 2022

• Advocacy groups support patient engagement in MDUFA V, raise concerns about device safety

  April 20, 2022

• Pear's VR product for postoperative pain granted FDA STeP designation

  April 14, 2022

• California appeals court orders J&J to pay $302M for deceptive surgical mesh marketing

  April 12, 2022

• Can digital therapeutics become profitable?

  April 11, 2022

• FDA clarifies cybersecurity recommendations for device makers in new guidance

  April 7, 2022

• Senators drill down on rising user fees, cybersecurity and clinical trial diversity in MDUFA hearing

  April 6, 2022

• Medical device user fee update inches closer to approval

  April 4, 2022

• Congress questions FDA, industry over MDUFA V delays

  March 31, 2022

• Pear expects $22M in revenue this year, as it banks on growing adoption of digital therapeutics

  March 29, 2022

• ResMed CEO expects another tough quarter as supply chain woes continue

  March 24, 2022

• FDA sets terms for MDUFA V agreement

  March 23, 2022

• US appeals court rules in favor of Nevro in patent dispute with Boston Scientific

  March 21, 2022

• ZimVie CEO talks company spinoff, new technologies

  March 14, 2022

• Akili plans to go public as it prepares to market video game treatment

  March 10, 2022

• As ortho procedures recover, Stryker turns focus to supply chain

  March 8, 2022

• Industry supports FDA's proposed quality system regulations, but says more time needed to adjust

  March 3, 2022

• Sanofi strikes $30M strategic agreement with digital health company DarioHealth

  March 2, 2022

• Boston Scientific touts early results of real-world Watchman FLX study

  March 1, 2022

• CMS code seen as major step toward reimbursement for digital therapeutics

  Feb. 25, 2022

• ResMed says it can't keep up with surging demand amid Philips recall

  Feb. 24, 2022

• What does a more aggressive M&A approach mean for J&J's devices unit?

  Feb. 22, 2022

• FDA publishes proposed rule to align quality system requirements with international standards

  Feb. 22, 2022

• Baxter infusion pump recall labeled Class I by FDA

  Feb. 22, 2022

• Baxter begins integrating Hillrom, faces supply chain pressures

  Feb. 17, 2022

• CDRH digital health chief talks new role with agency, future of the market

  Feb. 14, 2022

• Healthcare staffing shortages a 'rising concern' for medtechs: Moody's

  Feb. 9, 2022

• Thermo Fisher, Hologic plan for extended test demand in 2022

  Feb. 3, 2022

• Roundup: Latest earnings show medtechs grappling with healthcare staffing shortages, supply chain

  Jan. 31, 2022

• Edwards sees hospital capacity slow TAVR procedures, keeps 2022 guidance

  Jan. 27, 2022

• Medtech earnings season shows bumpy end to 2021 for some, bonanza for others

  Jan. 24, 2022

• Intuitive shares slide 11% after company cautions about omicron hit in Q1

  Jan. 21, 2022

• Cybersecurity leads ECRI's list of top medtech hazards for 2022

  Jan. 18, 2022

• Intuitive's da Vinci shipments beat Q4 expectations, COVID-19 impact to last through 2022

  Jan. 13, 2022