Medical Devices: Page 75
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‘Inadequate’ progress of Bayer’s study on birth-control implant called out by FDA as patients drop out
The FDA saw a rise in patients dropping out of a study on the Essure birth-control implant, prompting it to tell Bayer to develop and implement strategies to ensure the work continues.
By Nick Paul Taylor • Oct. 7, 2022 -
Retrieved from Abbott/PRNewswire on June 15, 2020
Dexcom, Abbott have ‘massive opportunity’ with new CGM coverage proposal: analysts
Analysts at J.P. Morgan said the proposal reads “very favorably” for the two leading makers of continuous glucose monitors and unlocks “a major near-term driver for growth.”
By Nick Paul Taylor • Oct. 7, 2022 -
Explore the Trendline➔
Sara Silbiger via Getty ImagesTrendlineTop 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 -
BD discloses cybersecurity vulnerability in cervical cytology processing machine
The company is advising users to address the threat by restricting access to the instrument while it works on a software patch.
By Nick Paul Taylor • Oct. 6, 2022 -
Dexcom starts global rollout of G7 CGM system, launching device in U.K. and Germany
Software updates have delayed the introduction of the product in the U.S. at a time when the company seeks to take market share from rival Abbott.
By Nick Paul Taylor • Oct. 6, 2022 -
Deep Dive
Medtech companies shift strategy as more orthopedic procedures move to ambulatory surgical centers
Many ASCs are looking for cashless options to get capital equipment as they offset the cost of new buildings, Zimmer Biomet COO Ivan Tornos said.
By Elise Reuter • Oct. 5, 2022 -
Medical machine-learning studies lack high-quality clinical trials, review shows
The findings “highlight areas of concern regarding the quality of medical machine learning RCTs and suggest opportunities to improve reporting.”
By Nick Paul Taylor • Oct. 4, 2022 -
LivaNova recall of open-heart-surgery blood pump designated as Class I event by FDA
A software malfunction can mistakenly freeze the machine, set off an alarm that can’t be muted and lead to the heart pump stopping during surgery.
By Nick Paul Taylor • Updated Oct. 12, 2022 -
Medtech groups praise MDUFA passage as legislators plan to include reforms in end-of-year bill
The legislation will provide the FDA with as much as $1.9 billion over the next five years, but changes to diagnostics and medical device cybersecurity were slashed from a "clean version" of the bill.
By Elise Reuter • Oct. 3, 2022 -
Illumina ushers in $200 genome with the launch of new sequencers
The company’s machines are part of a long line of products that have enabled Illumina to dominate the market for short-read sequencing.
By Nick Paul Taylor • Oct. 3, 2022 -
European AI Act could have ‘significant impact’ on manufacturers, medtech group warns
“Overregulation and misalignment” could create uncertainty and stop products from coming to market, MedTech Europe says.
By Nick Paul Taylor • Oct. 3, 2022 -
Pulse oximeter bias delayed treatment of Black COVID-19 patients by hours: study
An author of the paper called for manufacturers to “go back to the drawing board to provide clinicians with a tool that is free from bias.”
By Nick Paul Taylor • Sept. 30, 2022 -
Philips
Philips shareholders officially appoint Jakobs as CEO, president
Jakobs is Philips’ chief business leader for the connected care unit and has helped with the company’s recall of millions of sleep apnea and ventilator devices.
By Ricky Zipp • Sept. 30, 2022 -
Q&A
Friday Q&A: iRhythm CEO Quentin Blackford on how the heart monitor maker plans to reach $1B in sales
Continuing the company’s success in the U.S. and expanding internationally are the two biggest factors to achieving its $1 billion forecast, says Blackford.
By Ricky Zipp • Sept. 30, 2022 -
Veterans Affairs, FDA partner to accelerate medical device development
The goal is to provide standardized, off-the-shelf tests that can streamline the regulatory process and reduce time to market.
By Nick Paul Taylor • Sept. 30, 2022 -
Congress passes continuing resolution reauthorizing FDA user fees; bill heads to Biden for signature
President Biden is expected to sign last-minute deal to fund the government, that includes a “clean” bill without amendments to fund FDA review activities for five years.
By Elise Reuter • Updated Sept. 30, 2022 -
Bionic pancreas led to lower blood sugar levels than standard of care: study
The results point to the potential for a simplified approach for automated insulin delivery that could be particularly useful for patients without regular access to an endocrinologist.
By Elise Reuter • Sept. 29, 2022 -
Cyber risks identified in Canon Medical product used to view medical images, security firm says
Vulnerabilities in Canon Medical’s Vitrea View product could provide access to patient information and other services, according to cybersecurity firm Trustwave Spiderlab.
By Ricky Zipp • Updated Sept. 30, 2022 -
B. Braun acquires suite of catheter securement products from Starboard medical for undisclosed amount
The six acquired devices would improve patient care and extend B. Braun’s position in IV therapy, the company says.
By Elise Reuter • Sept. 28, 2022 -
FDA makes case for ‘new regulatory paradigm’ amid hurdles in software-oversight program
The agency seeks to tailor requirements based on the latest science, the benefits and risks posed by devices, their real-world performance and their contribution to promoting health equity.
By Nick Paul Taylor • Sept. 27, 2022 -
Hospital procedures have remained steady since H2 in boost for medtechs, survey finds
Evercore ISI analysts said the findings bode well for device companies, even as hospitals expect capital spending to drop next year.
By Elise Reuter • Sept. 26, 2022 -
Philips’ latest BiPAP machine recall labeled Class I event by FDA
Certain bi-level positive airway pressure devices feature plastic that could cause machines to stop working suddenly, potentially leading to serious injury or death, the FDA said Friday.
By Nick Paul Taylor • Sept. 26, 2022 -
Sponsored by Esper
Pros and cons of custom devices for HealthTech use cases
To meet the needs of both your specific use case and strict regulations, should you go custom?
Sept. 26, 2022 -
Device makers with ethylene oxide facilities at risk of lawsuits after Sterigenics loss: Needham
The $363 million award in the Sterigenics lawsuit “could lead to increased aggressiveness on the part of attorneys,” Needham analysts warned in a Friday note to investors.
By Ricky Zipp • Sept. 23, 2022 -
Forget oximeters, smartphone cameras detect 79% of cases of low blood oxygen in small study
If the results are validated by wider studies, physicians will have a new tool to increase the number of people who can be monitored for chronic and acute respiratory conditions.
By Nick Paul Taylor • Sept. 23, 2022 -
Courtesy of https://filecache.mediaroom.com/mr5mr_medtronic/183509/SURTAVI%20%28002%29%209.21%20600pix.png
Medtronic gets first FDA approval for drug-eluting stent in bifurcation lesions
Researchers have found the one-device, provisional stenting method delivers better results than two stents in some patients.
By Nick Paul Taylor • Sept. 22, 2022