FDA: Page 30
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Sascha Schuermann via Getty Images
Baxter gets 510(k) clearance for syringe pump, spurring optimism of faster FDA review process
Syringe pumps are a potential new driver of growth for Baxter, and analysts at J.P. Morgan called the clearance “a nice win for the company,” as FDA timelines for pumps more broadly have remained “a challenge” for medtech companies.
By Nick Paul Taylor • Sept. 1, 2022 -
Retrieved from Integra Life on August 24, 2022
Malfunctioning Integra intracranial monitor was used on patient who died: FDA
The team caring for the patient had to replace the sensor in a malfunctioning monitor, but Integra determined that the death was unrelated to the device, the agency said.
By Nick Paul Taylor • Sept. 1, 2022 -
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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 -
Retrieved from Hamilton website on August 30, 2022
Recall Watch: Hamilton ventilator, Intera pump recalls get Class I label from FDA
The FDA assigned the recalls to its most serious risk category in light of the potential for serious injuries and deaths.
By Nick Paul Taylor • Aug. 30, 2022 -
Patrik Stollarz / Staff via Getty Images
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 -
John Moore / Staff via Getty Images
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 -
Courtesy of Medtronic
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 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 -
N/A via Getty Images
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 -
Karen Ducey/Getty Images via Getty Images
Lab group ACLA warns ‘inadequate’ payment rates may limit access to monkeypox testing
The trade group urged the CMS to ensure monkeypox testing claims are paid at its “reasonably derived” recommended rate to ensure access to testing.
By Nick Paul Taylor • Aug. 23, 2022 -
Courtesy of Insulet Corp.
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 -
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 -
Permission granted by Eargo
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 -
gchutka via Getty Images
Visibly wins FDA clearance for self-administered online vision test
The agency has placed restrictions on the test, limiting it to adults aged 22 to 40 years and cautioning that it only gives “supportive recommendations.”
By Nick Paul Taylor • Aug. 17, 2022 -
Patrik Stollarz / Staff via Getty Images
FDA reviews rise in Philips respiratory device reports, including 44 deaths
The agency received more than twice as many reports linked to foam breakdown from May to July than from April 2021 to April 2022.
By Nick Paul Taylor • Aug. 17, 2022 -
Ijubaphoto via Getty Images
Hearing aids to be available over the counter following final FDA rule
Hearing aids were introduced for over-the-counter purchase in mid-October
By Elise Reuter • Aug. 16, 2022 -
Permission granted by Becton Dickinson
BD’s recall of emergency vascular access devices labeled Class I event by FDA
The company first announced the recall in June. There have been no reports of serious injuries or deaths tied to the issue.
By Nick Paul Taylor • Aug. 15, 2022 -
Sean Gallup via Getty Images
‘Underfunded’ FDA falls short in ensuring medical devices protect against cyberattacks, experts say
Medical device manufacturers argue the agency’s current rules on cybersecurity requirements are too restrictive and should be phased in gradually.
By Elise Reuter • Aug. 11, 2022 -
Medtronic issues Class I recall of implantable cardioverter defibrillators in U.S.
The devices may deliver a reduced shock during high-voltage therapy, about 79% of the programmed energy.
By Nick Paul Taylor • Aug. 11, 2022 -
Boston Scientific says it’s investigating allegations of anti-bribery law violations
The company says the issue is centered on its operations in Vietnam.
By Nick Paul Taylor • Aug. 10, 2022 -
Spencer Platt/Getty Images via Getty Images
Eargo’s Q2 revenue slides amid decline in hearing-aid shipments
The company’s gross system shipments fell by more than 8,000 when compared to the year-earlier period.
By Ricky Zipp • Aug. 9, 2022 -
Sarah Silbiger via Getty Images
FDA’s hearing-aid guidance clears regulatory review amid push by lawmakers for OTC sales
The move comes after the agency proposed the creation of a new category of over-the-counter hearing aids in October.
By Nick Paul Taylor • Aug. 9, 2022 -
Naomi Eide/MedTech Dive
Senate passes $740B bill to lower healthcare costs after months of wrangling
While Republicans successfully challenged a planned $35 insulin price ceiling for patients on private insurance, the law still has implications for makers of diabetes devices.
By Nick Paul Taylor • Aug. 8, 2022 -
Sarah Silbiger via Getty Images
FDA’s breakthrough device designations poised for another record year
At the midpoint of the year, the FDA had granted 129 designations, suggesting it will break the previous full-year record of 206.
By Nick Paul Taylor • Aug. 8, 2022 -
Courtesy of Suralignhttps://www.surgalign.com/wp-content/uploads/2020/07/Spine.png
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
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