Medical Devices: Page 71
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Retrieved from Olympus on August 30, 2022
Olympus to sell microscope unit for $3.1B as it bolsters focus on medical technology
Bain Capital has taken the other side of the deal, paying $3.1 billion for a business it said is “at the frontier of digital optical technology in life sciences and industrial end markets.”
By Nick Paul Taylor • Aug. 30, 2022 -
Abbott HeartMate 3 LVAD shows improved survival rate compared to older heart pump
After five years, Abbott found that patients implanted with the HeartMate 3 LVAD had an improved survival rate compared to those implanted with the HeartMate II.
By Elise Reuter • Aug. 29, 2022 -
Explore the Trendline➔
Sitthiphong via Getty ImagesTrendlineMedical 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 -
Philips recalls some BiPAP machines because of contaminated plastic
The FDA said the latest action is not associated with the company’s sleep apnea machine recall, although some devices are affected by both.
By Ricky Zipp • Aug. 29, 2022 -
Medtronic’s extravascular ICD meets safety, efficacy endpoints in recent study
The data could give Medtronic a competitor to Boston Scientific’s subcutaneous implantable defibrillator system.
By Elise Reuter • Aug. 29, 2022 -
FDA takes N95 respirators off medical device shortage list
Respirators were one of the first medical devices identified as being in critical shortage during the COVID-19 public health emergency, the agency said.
By Ricky Zipp • Aug. 29, 2022 -
Q&A
Akili CEO Martucci sees ‘massive’ need for company’s ADHD video-game treatment
With enough cash now to last two years, the company hopes it can change the way children with ADHD are treated, offering an alternative to pharmaceuticals.
By Elise Reuter • Aug. 29, 2022 -
Courtesy of https://news.medtronic.com/Left-Ventricular-Assist-Device-For-Advanced-Heart-Failure#assets_34137_10-122:19299
Medtronic reports six more injuries, one additional death related to HVAD battery problems
The company pulled the heart pump from the market last year, after the FDA received word of more than 3,000 deaths linked to various problems with the device, according to published reports.
By Elise Reuter • Aug. 26, 2022 -
Penumbra’s catheters achieve first-pass revascularization in 68.9% of stroke patients
A separate study found the device cleared clots in patients with tandem lesions, meeting the criteria for successful restoration of blood flow in 84% of subjects.
By Nick Paul Taylor • Aug. 26, 2022 -
Review finds ‘paucity of robust evidence’ on impact of AI clinical outcomes
Of the nearly 12,000 articles on artificial intelligence, only 39 described randomized controlled trials, making it difficult to quantify the clinical benefits of using AI-assisted tools for patient care.
By Nick Paul Taylor • Aug. 26, 2022 -
Medtronic gets CE mark for drug-eluting stent and kicks off European launch
Medtronic calculated that changes to the stent resulted in a 16% improvement in drug deliverability.
By Nick Paul Taylor • Aug. 25, 2022 -
Retrieved from Integra Life on August 24, 2022
Integra pulls intracranial pressure monitors for inaccurate readings
After announcing an immediate voluntary removal of the devices, Integra trimmed its sales forecast for the quarter.
By Elise Reuter • Aug. 24, 2022 -
Retrieved from Abbott.com on August 24, 2022
Abbott wins FDA approval for spinal cord stimulation treatment of multi-site pain
The approval gives Abbott a new angle as it seeks to win market share from Boston Scientific, Medtronic and Nevro.
By Nick Paul Taylor • Aug. 24, 2022 -
Courtesy of https://news.getinge.com/hs-fs/hubfs/CUsersu4003864DesktopServo-u%204.0-1.jpg?width=1800&name=CUsersu4003864DesktopServo-u%204.0-1.jpg
Getinge’s recall of 11,000 ventilators labeled Class I event by FDA
The company is fixing a software bug that can inadvertently stop the ventilator from working.
By Nick Paul Taylor • Aug. 24, 2022 -
Philips respirator lawsuit builds as plaintiffs’ attorneys outline lengthy recall delays
New filings in a class action lawsuit allege that Philips waited years to disclose the risk of foam used in its sleep apnea machines and respirators, causing illness and injuries.
By Elise Reuter , Peter Green • Updated Aug. 23, 2022 -
Medtronic CEO says supply chain starting to stabilize as sales dropped, profits rose in Q1
The company is keeping its revenue forecast for fiscal year 2023 as it works to resolve issues with packaging and resins.
By Elise Reuter • Aug. 23, 2022 -
Insulet’s Omnipod 5 insulin delivery system approved for preschool children
Adding preschoolers will broaden the market for the Omnipod after the launch of the device for people aged six years and older helped Insulet boost U.S. sales by 31% in the second quarter.
By Nick Paul Taylor • Aug. 23, 2022 -
Teleflex will buy Standard Bariatrics for $170M to gain Titan stapler
Standard’s investors could receive an additional $130 million if the unit reaches certain commercial milestones under Teleflex’s ownership.
By Elise Reuter • Aug. 22, 2022 -
Laser vision correction procedures fell 16% in the second quarter
The slowdown raises questions about whether demand is waning or if there was a pull-through in procedures last year.
By Elise Reuter • Aug. 22, 2022 -
Medical device industry poised to withstand an economic slowdown, experts say
While procedures volumes may decline, analysts said the effects likely won’t reach levels seen in 2020 or during the Great Recession.
By Ricky Zipp • Aug. 22, 2022 -
Edwards gets CE mark for Pascal Precision system, allowing device to be marketed in Europe
The system, which is used to treat patients with mitral or tricuspid regurgitation, is also expected to get FDA approval by the end of the year.
By Elise Reuter • Aug. 19, 2022 -
Q&A
Friday Q&A: ResMed CEO Mick Farrell discusses Philips recall, improving supply chain, prioritizing patients
The executive spoke about managing a 12-month patient backlog following a spike in demand due to Philips’ recall and supply constraints.
By Ricky Zipp • Aug. 19, 2022 -
Medtronic gets third Class I label in 2022 for latest HVAD recall
The latest recall is for nearly 40,000 batteries for the HeartWare Ventricular Assist Device system.
By Ricky Zipp • Aug. 19, 2022 -
Eargo plans to sell its hearing aids in stores after over-the-counter ruling
Best Buy, which announced it would sell over-the-counter hearing aids in more than 300 stores, has listed the Eargo 6 as one of the products it will offer.
By Elise Reuter • Aug. 18, 2022 -
Medical device recalls hit two-year high in Q2, report finds
While the number of recalls jumped in the period, the total units affected dropped to the lowest point in five years.
By Ricky Zipp • Aug. 18, 2022 -
New entrants may shake up hearing-aid market after FDA clears path for OTC sales
Startups, large tech companies and even traditional hearing-aid manufacturers are expected to offer over-the-counter devices.
By Elise Reuter • Aug. 17, 2022