Medical Devices: Page 55
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Courtesy of Imactis
GE HealthCare to buy France’s IMACTIS in first acquisition as independent firm
IMACTIS’s CT-Navigation system is used to help surgeons in minimally invasive operations and reduce procedure time.
By Peter Green • Jan. 11, 2023 -
Courtesy of U.S. Food and Drug Administration
Rethinking 510(k): Studies show risk of using recalled devices as predicates for FDA clearance
Two studies found devices cleared through the FDA’s 510(k) pathway that listed recalled predicate devices were more likely to face recalls themselves.
By Nick Paul Taylor • Jan. 11, 2023 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical 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 -
Courtesy of Sterigenics
Sterigenics reaches $408M ethylene oxide settlement to resolve hundreds of lawsuits in Illinois
Sterigenics said “years of biased media coverage in the greater Chicago area” underpinned its decision to settle.
By Nick Paul Taylor • Jan. 11, 2023 -
Permission granted by Abbott Laboratories
How Abbott plans to make its Freestyle Libre a $10B product
CEO Robert Ford discussed plans to grow the market for Abbott’s continuous glucose monitors, and its broader diabetes strategy.
By Elise Reuter • Jan. 10, 2023 -
Courtesy of Beta Bionics
Beta Bionics hires Harvard diabetes expert as CMO ahead of artificial pancreas launch
Steven Russell has joined the company as chief medical officer, completing a new leadership team that began taking shape with the appointment of Sean Saint as CEO last year.
By Nick Paul Taylor • Jan. 10, 2023 -
Permission granted by ResMed
ResMed responds to ‘humanitarian emergency’ over demand for CPAP devices with new factory
The company has scaled up its manufacturing capacity and struck agreements with chip suppliers even as patients still face waits for the devices amid ongoing recall woes at Philips.
By Elise Reuter • Jan. 10, 2023 -
Permission granted by iRhythm Technologies
Cardiac wearable maker iRhythm sees ‘nice progress’ in recovering from Q3 challenges
The company reported more than 20% growth in patient registration and improvement in its returned device rate.
By Nick Paul Taylor • Jan. 10, 2023 -
Permission granted by Medtronic
Medtronic CEO Martha: No more divestitures planned for 2023, but review continues
“The portfolio review is ongoing,” CEO Geoff Martha said, even as the world's largest medtech company plans to divest dialysis, respiratory interventions and patient monitoring businesses.
By Elise Reuter • Jan. 9, 2023 -
John Moore via Getty Images
Dental medtech market remains steady amid ‘robust’ US employment: Henry Schein
Analysts said the update from company executives is encouraging, although there are potential concerns about pricing.
By Nick Paul Taylor • Jan. 9, 2023 -
artJazz via Getty Images
European Commission formalizes plan to extend MDR transition out to 2027, 2028
Having accepted that notified body capacity “remains insufficient,” the Commission wants to give manufacturers more time to get their devices designated under MDR.
By Nick Paul Taylor • Jan. 9, 2023 -
Tim Boyle via Getty Images
Baxter to spin off renal care, acute therapies units
The company is also considering the sale of its Biopharma Solutions business.
By Elise Reuter • Jan. 6, 2023 -
Sarah Silbiger via Getty Images
Vivos bounces back from FDA rejection to land 510(k) clearance for sleep apnea treatment
Shares in Vivos increased by more than 150% on the day of the news.
By Nick Paul Taylor • Jan. 6, 2023 -
Courtesy of GE Healthcare
Q&AFriday Q&A: For GE HealthCare, the future is digital, CEO Arduini says
Digital capabilities will be “the next big inflection” driving growth for GE’s newly independent healthcare business.
By Peter Green • Jan. 6, 2023 -
SciePro via Getty Images
Novocure shares jump on positive lung cancer data
A regimen involving the Swiss biotech’s electrical field-based treatment extended lives in a late-stage trial. But data comparing the medical device to standard chemotherapy is less persuasive.
By Jonathan Gardner • Jan. 5, 2023 -
Courtesy of Embody
Zimmer to acquire soft tissue repair firm Embody for as much as $275M
Buying Embody’s repair system for tendons and ligaments will expand Zimmer Biomet’s share in the growing sports medicine market.
By Elise Reuter • Jan. 5, 2023 -
Peter S Green/MedTech Dive
GE HealthCare starts trading on Nasdaq as independent company
The company’s stock gained in morning trading after debuting at $56 per share.
By Elise Reuter • Jan. 4, 2023 -
Courtesy of Medtronic
‘Mea culpa’: What Goldman Sachs analysts got wrong about Medtronic in 2022
Medtronic has struggled to deliver on key projects in recent years, leading to a decline in its stock performance.
By Nick Paul Taylor • Jan. 4, 2023 -
Retrieved from LinkedIn on January 04, 2023
ReCor names Healthineers exec Barghout as CEO ahead of showdown with Medtronic
ReCor is preparing to go up against Medtronic with its renal denervation system, in a market that the latter expects to grow to $3 billion by the end of the decade.
By Nick Paul Taylor • Jan. 4, 2023 -
Courtesy of AliveCor
Apple infringed on AliveCor wearable patents, ITC says in final ruling; import ban suspended
The commission found that Apple has infringed on two AliveCor patents and thereby violated a law that can trigger an import ban.
By Nick Paul Taylor • Jan. 4, 2023 -
ryasick via Getty Images
Deep DiveA look back at medtech’s top 10 acquisitions of 2022
While larger acquisitions were announced at the end of the year including J&J’s $16.6B purchase of Abiomed, the number of deals declined from 2021.
By Elise Reuter • Dec. 22, 2022 -
Mario Tama via Getty Images
J&J closes acquisition of heart pump maker Abiomed
The $16.6 billion purchase was the largest medtech transaction of 2022.
By Elise Reuter • Dec. 22, 2022 -
Courtesy of Philips
Philips’ studies argue recalled DreamStation CPAP machines unlikely to harm patients’ health
In a briefing on testing of the machines, Philips said exposure to degraded foam used to soundproof the devices is unlikely to harm patients.
By Elise Reuter • Dec. 21, 2022 -
Brendan Hoffman via Getty Images
Diagnostic testing reform missing from Congress’ year-end spending bill
A provision that would have brought in-vitro diagnostic tests and lab-developed tests under one regulatory framework was not included in the omnibus spending bill.
By Elise Reuter • Dec. 21, 2022 -
Courtesy of Odin Vision
Olympus agrees to $80M takeover of artificial intelligence endoscopy startup Odin Vision
The acquisition gives Olympus control of cloud-based AI systems to help detect and characterize cancerous and precancerous tissues during colonoscopies and gastroscopies.
By Nick Paul Taylor • Dec. 21, 2022 -
Pixelseffect via Getty Images
As diabetes technology advances, blood glucose control declines: study
Mexican-American and non-Hispanic Black adults saw the greatest drop as the proportion of patients with glycemic control fell from 29.2% between 1988 and 1994 to 27.5% between 2013 and 2020.
By Nick Paul Taylor • Dec. 21, 2022
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