FDA clears next-gen hemostasis system from HemoSonics

The Quantra hemostasis system (left) and QStat cartridge (right). [Images courtesy of HemoSonics]HemoSonics announced today that it received FDA 510(k) clearance for its Quantra hemostasis system with the QStat cartridge.

FDA clearance expands the Quantra system’s indications to include trauma and liver transplantation procedures.

Durham, North Carolina-based HemoSonics designed the next-generation system to increase Quanta’s overall diagnostic capabilities. It covers the broadest range of indications of any point-of-care hemostasis analyzer in the U.S., according to a news release.

“The Quantra Hemostasis System with QStat Cartridge is breaking new ground and leading innovation in the point-of-care and laboratory-based whole blood hemostasis testing market,” said Robert Roda, HemoSonics president and CEO. “Today’s clearance significantly expands the clinical indications of the Quantra System, creating the greatest opport…

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Electromed wins FDA clearance for next-gen airway clearance generator

Electromed (NYSE:ELMD) announced today that it received FDA 510(k) clearance for its SmartVest Clearway airway clearance system.

New Prague, Minnesota-based Electromed designed the system for high-frequency chest wall oscillation (HFCWO) therapy. It represents the fifth generation of Electromed’s technology.

According to a news release, the updated approach to HFCWO offers an enhanced patient experience with proven patient outcomes.

“It is our goal to make home airway clearance easier and more convenient for patients, while continuing to provide a superior product, proven outcomes, and outstanding patient service,” said Kathleen Skarvan, president and CEO of Electromed. “SmartVest Clearway meets these goals with its intuitive touch screen, the lightest weight generator on the market, and smaller footprint than our previous generation, which continues our history of innovation in HFCWO therapy.

“We are proud to further our mission and a…

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Baxter’s smart incontinence pad recall is Class I

The WatchCare system is a smart incontinence pad that integrates into healthcare facility bed. [Image courtesy of Baxter]The FDA issued a notice declaring the Baxter (NYSE:BAX) WatchCare incontinence management system (IMS) recall as Class I, the most serious kind.

Baxter last month issued an urgent medical device correction for the WatchCare IMS. The system appears to radiate radiofrequency (RF) that may affect other devices on caregivers and patients. The list of potentially affected devices includes infusion/insulin pumps, blood glucose sensors, fetal monitors/dopplers, telemetry devices and bladder scanners.

Other third-party medical devices may be affected, too, according to the FDA notice. RF interference could cause erroneous readings or malfunctions of the devices on both patients and staff.

Baxter reported 96 complaints of RF interference. To date, all cases but two experienced interference at a distance less than one meter. The company said it has…

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Cardinal Health expands single-use device reprocessing facility

Cardinal Health’s Sustainable Technologies facility in Riverview, Florida [Photo courtesy of Cardinal Health]

Cardinal Health (NYSE:CAH) recently opened its expanded Sustainable Technologies facility in Riverview, Florida.

The facility is now twice as large as before, at 100,000 square feet, said Dublin, Ohio-based Cardinal Health.

The medical device manufacturer and distributor launched Sustainable Technologies in 2015 to collect, reprocess and recycle single-use devices in the U.S. Sustainable Technologies now works with more than 3,000 U.S. hospitals and ambulatory service centers, Cardinal Health said.

The FDA allows single-use devices to be used more than once if reprocessors can show the reprocessed devices are substantially equivalent to the original device. Many single-use devices can be recycled when they can not be reprocessed.

NEED TO KNOW: Ramping up manufacturing for sing…

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Zimmer Biomet’s 3D-printed tibia receives FDA clearance

The Persona OsseoTi Keel Tibia. [Image from Zimmer Biomet]Zimmer Biomet (NYSE:ZBH) announced today that it received FDA 510(k) clearance for the Persona OsseoTi Keel Tibia.

Warsaw, Indiana-based Zimmer Biomet designed the system for cementless knee replacement. It represents the latest addition to the Persona Knee system platform.

Persona OsseoTi features a new porous version of the Persona anatomic tibia. It includes the Zimmer Biomet OsseoTi porous medical technology. That uses anatomical data with 3D printing technology.

The technology helps to build a structure that directly mimics the architecture of human cancellous (spongey) bone. Combined with a keeled design, it delivers stable initial and biological fixation, according to Zimmer Biomet.

Clearance helps Zimmer Biomet “close out the year” strong

“With an increasing number of surgeons opting for cementless procedures for their patients, we are excited to expand our market-lea…

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FDA could allow OTC sales of opioid overdose drug naloxone

The FDA announced that it encourages companies to develop nonprescription naloxone drugs to help reduce opioid overdoses.

Certain naloxone hydrochloride drug products may be “approvable as safe and effective for nonprescription use,” the agency explained in a draft Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use.

FDA has reached a preliminary opinion that the drug has the potential to be safe and effective when used in an unsupervised nonprescription setting at a dose of up 4 mg as a nasal spray and up to 2 mg when used in an intramuscular or subcutaneous autoinjector.

“Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” said FDA Commissioner Dr. Robert M. Califf, in a news release. “The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for a…

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FDA clears Neocis surgical robot for bone reduction

The Yomi surgical robot. [Image from Neocis]Neocis announced today that it received FDA 510(k) clearance for its Yomi surgical robot system for use in guided bone reduction.

This represents the second FDA clearance for Neocis this year, and its 14th in total.

Miami-based Neocis designed its Yomi surgical robot for dental surgery. It assists clinicians in the planning and operative phases of dental implant placement. For example, Yomi offers interactive digital planning software and physical guidance for surgical instrumentation.

The new indication for Yomi allows dental professionals to perform robot-guided alveoloplasty of the mandible and/or maxilla. This is commonly referred to as bone reduction, according to a news release.

A CT scan of the patient digitally plans the bone reduction and placement of implants. During the procedure, Yomi’s guide arm provides haptic feedback. This keeps the burr from deviating beyond …

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FDA updates guidance on identifying and responding to deficiencies

Kathryn Burke, Emergo Group

The FDA has revised the guidance document Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions to update the considerations on identifying and responding to deficiencies in premarket submissions. The document supersedes the one of the same title issued on Nov. 2, 2000.

The revised document further clarifies the content and format of a deficiency letter and includes a new list of examples of deficiencies and applicant responses.

Guidance on requesting additional information for market registration

The FDA has finalized the guidance document​ to help agency staff develop requests for additional information needed to make a decision on a medical device marketing application. Requests for additional information for medical device marketing applications are known as deficiencies. The guidance also recommends the most efficient formats for agency and industry to send or reply to such deficienc…

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Navigating MDR’s newly charted waters

Compliance with the EU’s MDR often requires multidisciplinary collaboration between a device maker’s operations, R&D, regulatory and quality teams, plus partners across the supply chain. [Photo courtesy of Avery Dennison Medical]

With the Medical Device Regulation in effect, European Union regulatory compliance requires rigorous attention and cross-functional collaboration.

Lisa Bartakovics, Avery Dennison Medical

Are you ready for MDR? That question has weighed on medical device manufacturers ever since the European Union proposed stronger device regulations and requirements.

After MDR became law in May 2017, the industry had four years to transition and comply. It’s been more than a year since MDR’s May 26, 2021, application date, yet there still is uncertainty regarding compliance requirements due to the lack of guidance documents and individual interpretation.

O…

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What does the future hold for AI in medical devices?

(Image courtesy of the FDA)

Digital health, artificial intelligence (AI), machine learning and more — these concepts continue to generate buzz in the medtech world.

Last month, the FDA published guidance on clinical decision support (CDS) software. It helped to clear up what constitutes a medical device and what doesn’t. Early last year, the agency published a predetermined change control plan (PCCP) to help build a regulatory structure for such technology.

These topics and more spurred intriguing commentary on a panel at AdvaMed’s MedTech Conference in Boston today.

The panel featured viewpoints across all angles of the space. Dr. Yuri Maricich, CMO and head of development at Pear Therapeutics, offered thoughts from the developer of digital therapeutics. Brendan O’Leary, acting director of the Digital Health Center of Excellence at the FDA, provided the regulatory vantage point.

Cybil Roehrenbeck, a partner at Hogan Lovells, off…

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What does the future hold for AI in medical devices?

(Image courtesy of the FDA)

Digital health, artificial intelligence (AI), machine learning and more — these concepts continue to generate buzz in the medtech world.

Last month, the FDA published guidance on clinical decision support (CDS) software. It helped to clear up what constitutes a medical device and what doesn’t. Early last year, the agency published a predetermined change control plan (PCCP) to help build a regulatory structure for such technology.

These topics and more spurred intriguing commentary on a panel at AdvaMed’s MedTech Conference in Boston today.

The panel featured viewpoints across all angles of the space. Dr. Yuri Maricich, CMO and head of development at Pear Therapeutics, offered thoughts from the developer of digital therapeutics. Brendan O’Leary, acting director of the Digital Health Center of Excellence at the FDA, provided the regulatory vantage po…

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Abiomed reaches new regulatory milestone for its Impella pumps

This screen shot from an Abiomed video demonstrates placement of the Impella 2.5 and Impella CP. Delivered in a minimally invasive way, Impella pumps actively unload the heart, aiding native heart recovery. [Image courtesy of Abiomed]Abiomed (Nasdaq:ABMD) announced that the FDA accepted and closed its post-approval study reports for its Impella heart pumps.

Danvers, Massachusetts-based Abiomed’s study reports relate to Impella’s premarket approvals (PMA). The company said in a news release that the FDA’s action represents “another affirmation” of the safety and effectiveness of Impella heart pumps.

Impella pumps treat cardiogenic shock, high-risk PCI and post-cardiotomy cardiogenic shock. They also cover cardiogenic shock in the setting of myocarditis or cardiomyopathy and right heart failure.

Abiomed said the FDA typically requires post-approval studies for medical devices under PMA. Post-approval studies use high-quality, pro…

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