LASIK again under microscope as FDA seeks comment on improving patient communication

Amid concerns patients are not receiving information on the risks and benefits of laser eye surgery, FDA’s draft guidance aims to protect consumers.

By Nick Paul Taylor • July 28, 2022

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

Industry leaders say the funding will strengthen U.S. innovation and speed the deployment of life-changing devices to patients.

By Elise Reuter • Updated July 28, 2022

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Stryker boosts sales forecast, sees steady demand from hospitals

In contrast to other medtech firms, the orthopedics company said it saw no changes in demand for its surgical robots in the second quarter.

By Elise Reuter • July 27, 2022

Boston Scientific managed COVID-19, economic pressures in Q2, expects procedures to increase

Macroeconomic challenges remain, company says, as it anticipates more consistent procedure volume growth in second half.

By Ricky Zipp • July 27, 2022

MedTech Europe pushes for semiconductor prioritization as US moves to increase local supply

The trade group wants political action to stop patient harm from “a growing divergence” between semiconductor supply and demand.

By Nick Paul Taylor • July 27, 2022

3M to spin out its healthcare business

The decision comes amid spin-offs by several large medtech firms, including J&J and GE.

By Elise Reuter • July 26, 2022

Biotronik to pay $12.95M to settle kickback allegations of 'lavish' meals, abuse of training programs

Federal prosecutors accused Biotronik of abusing a new employee program by paying physicians to provide “excessive” training and of funding lavish meals.

By Nick Paul Taylor • July 26, 2022

Baxter recalls Abacus pharma compounding software over risk of labeling errors

The FDA classified the recall as a Class I event and warned that inaccurate labels could seriously harm patients.

By Peter Green • July 26, 2022

GE expects supply chain issues to ease in second half after Q2 challenges for health unit

The company’s healthcare unit grew revenue by 1% year over year last quarter, while profit was down 19% compared to the second quarter of 2021.

By Ricky Zipp • July 26, 2022

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

The company made the announcement Monday during a second-quarter earnings call but provided few details.

By Ricky Zipp , Elise Reuter • Updated July 25, 2022

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

Sleep apnea machine recall adds to woes as sales forecast is slashed for remainder of 2022. 

By Elise Reuter • July 25, 2022

iRhythm, Alphabet unit Verily get FDA clearances for Zio Watch and software system

Bolstered by an AI algorithm, the companies’ partnership is a step closer to catching up with the Apple Watch.

By Ricky Zipp • July 25, 2022

Intuitive's da Vinci placements dropped in Q2 due to 'choppy' supply chain, tighter spending by hospitals

CEO Gary Guthart said the larger economic trends that pressured the company in the second quarter are poised to continue.

By Ricky Zipp • July 22, 2022

Smiths Medical's recall of syringe infusion pumps labeled Class I event after injuries, death

The company is asking customers to return devices if abnormal circuit board behavior causes the pump to stop.

By Nick Paul Taylor • July 21, 2022

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

The biotech company said the deal is an opportunity to grow its eye-care business.

By Elise Reuter • July 20, 2022

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

The advisory group addressed patient consent in surgeries using augmented reality tools and how to distinguish clinical uses of virtual reality from entertainment products. 

By Elise Reuter • July 20, 2022

Abbott's Q2 sales boosted by COVID-19 testing; outlook for diagnostics demand remains uncertain

The company’s $2.3 billion in COVID-19 testing sales beat J.P. Morgan and Stifel analysts’ estimates by about $1 billion, while CEO Robert Ford cautioned that forecasting demand remains challenging.

By Ricky Zipp • July 20, 2022

Defibrillators, chest drains added to FDA's list of device shortages

The defibrillator supply disruption reflects both increased demand and problems sourcing a component, part or accessory.

By Nick Paul Taylor • July 20, 2022

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

Despite foreign-exchange pressures, analysts said the results were an “encouraging starting point” as medtech companies begin reporting their quarterly earnings.

By Elise Reuter • July 19, 2022

iRhythm says Q2 unit volumes beat forecast, names Chad Patterson as new CCO

The company noted the results are preliminary and may change before its Aug. 4 earnings call.

By Ricky Zipp • July 19, 2022

Hologic's stock rating cut by BTIG amid worsening supply chain challenges, drop in COVID testing

The company is facing challenges including increasing operating expenses and shortages of semiconductor chips, according to the analyst report.

By Ricky Zipp • July 18, 2022

Notified bodies have yet to issue MDR certificates for 85% of legacy devices: survey

The EU's Medical Device Regulation certification process is taking twice as long as the old directive pathway and smaller companies are struggling to get started, the poll shows.

By Nick Paul Taylor • July 18, 2022

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

If legislation isn’t passed before the August recess, the FDA would have to furlough workers, slowing its review of medical device and pharmaceutical products. 

By Elise Reuter • July 15, 2022

Medtronic warns European healthcare providers of safety problem in defibrillators

The warning adds to Medtronic’s growing list of product safety issues over the last 18 months.

By Ricky Zipp • July 15, 2022

Abbott, Intuitive, J&J to kick off quarterly earnings season next week as recession threat looms

Earnings results are poised to set expectations for the impact of a potential slowdown and shed light on trends with implications for companies including Boston Scientific, Medtronic and Stryker.

By Nick Paul Taylor • July 15, 2022