Medical Devices: Page 6
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Sarah Silbiger via Getty Images
FDA warns 2 Chinese labs for oversight failures, animal care violations
The FDA said the problems “raise concerns about the quality and integrity of data generated by the labs,” which provide third-party testing and validation data services for device firms.
By Nick Paul Taylor • Sept. 12, 2024 -
Courtesy of Spectrawave
J&J leads $50M financing for imaging company Spectrawave
The Series B round will support commercial expansion and product additions for Spectrawave’s system used in the treatment of coronary artery disease.
By Susan Kelly • Sept. 11, 2024 -
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Sarah Silbiger via Getty Images
TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
Sarah Silbiger via Getty Images
FDA to investigate presence of metals in tampons
Members of the Democratic Women’s Caucus last week urged FDA Commissioner Robert Califf to address the safety concerns.
By Nick Paul Taylor • Sept. 11, 2024 -
Sarah Silbiger via Getty Images
Smiths Medical links 1 death, 35 injuries to defective airway tubes
Vivek Jain, CEO of parent ICU Medical, recently told investors the company has faced more challenges than expected when it bought the Smiths medical device business in 2022.
By Susan Kelly • Sept. 10, 2024 -
Justin Sullivan via Getty Images
Apple adding sleep apnea feature to smartwatch
Apple unveiled the health feature alongside new hearing aid capabilities for its Airpods Pro 2 earbuds.
By Nick Paul Taylor • Sept. 10, 2024 -
the rads via Getty Images
Many FDA-authorized AI devices lack validation data
About 43% of all AI-enabled devices cleared or approved by the FDA through 2022 were missing validation data, and only 28% were tested prospectively, according to a Nature Medicine study.
By Elise Reuter • Sept. 9, 2024 -
Mario Tama via Getty Images
Judge orders J&J to pay Auris investors more than $1B for merger violations
J&J did not provide Auris Health with resources to achieve regulatory milestones after acquiring the robotics company in 2019, the judge found.
By Ricky Zipp • Sept. 6, 2024 -
Courtesy of Abbott
Abbott debuts Lingo over-the-counter CGM in the US
Priced at $49 for one 14-day sensor, or $89 per month, Abbott’s offering is competitive with Dexcom’s Stelo sensor.
By Elise Reuter • Sept. 6, 2024 -
Permission granted by Abbott Laboratories
Abbott partners with maker of ‘bionic pancreas’
Abbott will integrate its latest glucose sensor with Beta Bionics’ automated insulin delivery system.
By Nick Paul Taylor • Sept. 5, 2024 -
Retrieved from The Food and Drug Administration.
FDA cracks down on ozone cleaners for CPAP machines
The agency sent warning letters to four companies and reminded the public it has not authorized any devices for cleaning or disinfecting CPAPs.
By Elise Reuter • Sept. 5, 2024 -
Courtesy of Edwards Lifesciences
Edwards cuts more than 500 employees after critical care sale
An Edwards spokesperson said the layoffs, affecting 3% of its workforce, are a “one-time right-sizing” deemed necessary following the division’s sale to BD.
By Susan Kelly • Sept. 5, 2024 -
Courtesy of Insightec
Medtech venture investment recovery continues, but startup M&A remains limited: Pitchbook
Acquisitions of late-stage VC startups have been rare, a fact Pitchbook attributed to “ongoing price gaps between buyers and sellers.”
By Nick Paul Taylor • Sept. 4, 2024 -
SDI Productions via Getty Images
European heart group recommends renal denervation for some patients
The European Society of Cardiology said the treatment may be considered for certain patients with uncontrolled, drug-resistant high blood pressure but outlined lingering concerns.
By Nick Paul Taylor • Sept. 4, 2024 -
Permission granted by Nasdaq
Embecta gets FDA nod for insulin patch pump
Embecta’s first patch pump features a larger insulin reservoir, based on feedback from people with Type 2 diabetes.
By Elise Reuter • Sept. 3, 2024 -
Courtesy of Grail
Illumina avoids fine for Grail purchase in European court victory
Illumina will avoid a penalty of 432 million euros after a court ruled the European Commission did not have jurisdiction to challenge the company’s Grail acquisition.
By Susan Kelly • Sept. 3, 2024 -
Sarah Silbiger via Getty Images
FDA finalizes Voluntary Malfunction Summary Reporting guidance
The agency clarified when companies can submit device malfunction reports in a quarterly summary, instead of individual reports every 30 days.
By Nick Paul Taylor • Aug. 30, 2024 -
Permission granted by Medtronic
Medtronic’s chief medical officer of acute care and monitoring departs for new role
Sam Ajizian leaves Medtronic six months after the company reversed a plan to split off its patient monitoring business.
By Nick Paul Taylor • Aug. 30, 2024 -
Courtesy of Penumbra
Penumbra axes virtual reality division, will lay off 71 people
CEO Adam Elsesser told investors the company’s focus needs to be on its core thrombectomy business as it cut its sales forecast for 2024.
By Elise Reuter • Aug. 29, 2024 -
Rob Carr / Staff via Getty Images
Johns Hopkins, CareFirst, Techstars launch healthcare AI accelerator
The 13-week program will offer funding and guidance to up to 12 health tech, medtech and biotech startups working on AI tools.
By Emily Olsen • Aug. 29, 2024 -
Courtesy of Boston Scientific
Boston Scientific receives CE mark for updated TAVR technology
Changes include the addition of a larger valve size that company executives have said will open up 25% of the market in Europe.
By Nick Paul Taylor • Aug. 28, 2024 -
Retrieved from UFP Technologies on August 27, 2024
UFP to buy device component maker AQF Medical, extending deal spree
AQF makes foam and thermoplastic components for use in medical devices and packaging.
By Nick Paul Taylor • Aug. 28, 2024 -
Permission granted by Insulet
Q&AInsulet’s Trang Ly on overcoming ‘clinical inertia’ in diabetes care
Automated insulin delivery for Type 2 patients can help change minds among physicians who have been reluctant to prescribe pump therapy, the chief medical officer said in an interview.
By Susan Kelly • Aug. 27, 2024 -
Kahan Shan via Getty Images
Inari updates label of clot removal device linked to 6 deaths
Inari recalled the catheter and revised instructions for use after reports of the device becoming entrapped or blocking patients’ lung arteries.
By Nick Paul Taylor • Aug. 27, 2024 -
Courtesy of Siemens Healthineers
Siemens Healthineers to grow PET imaging with purchase of Novartis assets
Siemens will pay 200 million euros for the manufacturing and distribution network of Novartis’ radiopharmaceutical molecular imaging business.
By Nick Paul Taylor • Aug. 27, 2024 -
Courtesy of Insulet
Insulet expands Omnipod 5 pump to people with Type 2 diabetes
The FDA clearance marks the first automated insulin delivery system for people with Type 2 diabetes.
By Elise Reuter • Aug. 26, 2024
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