Medical Devices: Page 80
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Permission granted by Zimmer Biomet
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 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Courtesy of Insulet Corp.
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 -
Sarah Silbiger via Getty Images
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 -
Courtesy of Dexcom, Nick Jonas Super Bowl kit
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 -
Permission granted by Eargo
Q&AFriday 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 -
FG Trade via Getty Images
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Amid concerns patients are not receiving information on the risks and benefits of laser eye surgery, FDA’s draft guidance aims to protect consumers.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 -
Megan Quinn/MedTech Dive
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 -
400tmax via Getty Images
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 -
Justin Sullivan via Getty Images
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 -
Don MacKinnon via Getty Images
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 -
bpperry via Getty Images
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 -
Retrieved from Baxter.com on 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 -
Drew Angerer via Getty Images
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 -
Patrik Stollarz / Staff via Getty Images
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 -
Permission granted by iRhythm Technologies
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 -
VCG / Stringer via Getty Images
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 -
Sarah Silbiger via Getty Images
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 -
seb_ra via Getty Images
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 -
doble-d via Getty Images
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 -
Courtesy of Abbott
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 -
Sarah Silbiger via Getty Images
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
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