iRhythm raises 2022 revenue forecast after record number of registrations in Q2

The cardiac monitor maker increased the low end of its forecast by $5 million, although executives expect a flat third quarter compared to the second quarter due to macroeconomic pressures.

By Ricky Zipp • Aug. 5, 2022

SEC accuses surgical implant business of pulling forward sales to hit targets

According to the SEC, Surgalign, known at the time as RTI Surgical, shipped future orders ahead of schedule to pull forward revenues and mask disappointing sales figures.

By Nick Paul Taylor • Aug. 5, 2022

Explore the Trendline➔

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

Hospitals have low level of accountability for connected device breaches

Of the 43% of organizations that reported a data breach in the past two years, 88% said at least one connected device was a contributing factor to the breach, according to a new report.

By Rebecca Pifer • Aug. 4, 2022

EPA names BD, Edwards and Medtronic on list of higher-risk sterilization facilities

AdvaMed said ethylene oxide is vital for prevention of serious infections and shutting facilities could disrupt the supply of medical devices.

By Nick Paul Taylor • Updated Aug. 5, 2022

BD’s base business growth in Q3 offset by drop in COVID-19 testing

The company reported a year-over-year drop of about $224 million in COVID-19 testing revenue compared to 2021, with the testing slowdown expected to continue. 

By Ricky Zipp • Aug. 4, 2022

Virtual Incision opens new frontier for robotic surgery with space station mission

Using a grant from NASA, the company will perform a mission on the International Space Station to show its platform’s suitability for long-duration space travel.

By Nick Paul Taylor • Aug. 3, 2022

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

The company saw sales across knee and hip procedures increase, though it still faces foreign currency and supply chain challenges.

By Elise Reuter • Aug. 2, 2022

Boston Scientific pays $85M to settle long-running patent dispute with Nevro

J.P. Morgan analysts said the settlement over spinal cord stimulation devices is “a dollar win for Nevro, but a longer-term competitive loss.”

By Nick Paul Taylor • Aug. 2, 2022

Insulet moves to full launch of Omnipod 5

BTIG analysts said the shift reflects success with user experience and logistics during a limited market release.

By Elise Reuter • Aug. 1, 2022

FDA extends Class I UDI submission deadline, exempts consumer health devices from requirements

The deadline extension should help manufacturers submit device identification data to an agency database, while freeing over-the-counter consumer devices from needless regulation.

By Nick Paul Taylor • Aug. 1, 2022

Edwards TAVR unit weighed down by hospital staffing shortages

CEO Mike Mussallem warns there "are going to be some casualties" if surgeries continue to be stalled.

By Elise Reuter • July 29, 2022

Dexcom’s G7 glucose monitor delayed until late 2022; stock price drops 5.6%

The CGM maker needs to update software for the product, pushing back the FDA’s decision and eventual U.S. release.

By Ricky Zipp • July 29, 2022

Friday Q&A: Eargo CEO Christian Gormsen talks OTC rule, challenging market leaders, DOJ settlement

New FDA regulations expected soon would boost firms like Eargo, allowing millions of Americans without hearing aids to buy them for less and without a prescription.

By Ricky Zipp • July 29, 2022

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

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