FDA Archives - Page 41 of 103 - Medical Design Sourcing

FDA approves IDE trial for Fractyl Health’s diabetes reversal tech in type 2 diabetes patients

Fractyl Health announced today that it received FDA approval for an investigational device exemption (IDE) trial of its diabetes reversal platform.

Lexington, Massachusetts-based Fractyl Health will evaluate its Revita treatment in patients with type 2 diabetes whose disease is inadequately controlled despite treatment with at least two antidiabetic agents (ADAs) and who are not yet on insulin in the Revitalize-2 IDE pivotal study.

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FDA approves Abbott’s leadless pacemaker for patients with slow heart rhythms

Abbott (NYSE:ABT) announced today that the FDA approved its Aveir single-chamber (VR) leadless pacemaker for slow heart rhythms.

In November 2021, the Abbott Park, Illinois-based company reported results from an FDA investigational device exemption (IDE) study that showed that Aveir met pre-specified primary endpoints in patients with certain abnormal heart rhythms, suggesting that, if approved, Aveir could aid those who require the use of a pacemaker to treat slow heart rhythms.

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FDA approves Abbott’s leadless pacemaker for patients with slow heart rhythms

Abbott (NYSE:ABT) announced today that the FDA approved its Aveir single-chamber (VR) leadless pacemaker for slow heart rhythms.

In November 2021, the Abbott Park, Illinois-based company reported results from an FDA investigational device exemption (IDE) study that showed that Aveir met pre-specified primary endpoints in patients with certain abnormal heart rhythms, suggesting that, if approved, Aveir could aid those who require the use of a pacemaker to treat slow heart rhythms.

Aveir is implanted directly into the right ventricle of the heart in a minimally invasive procedure. Abbott designed Aveir VR with a unique mapping capability that, according to a news release, allows physicians to measure electrical signals within the heart and determine the correct placement of the device before final implantation.

The leadless pacemaker has an increased projected battery life that Abbott said can last up to two times longer than other currently available lead…

Ultrasonically welded flow sensor critical to success of Hamilton Medical ventilator design

The body of the Hamilton Medical proximal flow sensor consists of two molded halves composed of medical-grade plastic. Between the two halves, a ring-shaped insert holds a delicate membrane with a variable orifice that detects changes in air direction and flow within the patient airway, transmitting inhalation/exhalation inputs to the ventilator digital control through two small tubes linked to the ports at center right. These inputs are used to minutely regulate air pressure and flow in real time. [Photo courtesy of Hamilton Medical]

The disposable sensor monitors ventilation of critically ill patients with high precision.

Didier Perret, Emerson

Hamilton Medical (Bonaduz, Switzerland) produces intelligent ventilation solutions for intensive-care units and critical-care transports. To meet the exploding demand for ventilators during the COVID-19 pandemic, Hamilton Medical established a new ventilator produ…

FDA approves Edwards Lifesciences’ tissue valve replacement for heart’s mitral position

Edwards Lifesciences (NYSE:EW) announced today that the FDA approved its Mitris Resilia tissue valve replacement system.

Irvine, California-based Edwards designed the Mitris Resilia valve with a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve. It features a low-profile frame for avoiding obstruction of the left ventricular outflow tract by stent posts and is visible under fluoroscopy to facilitate potential future transcatheter interventions.

According to a news release, the Mitris Resilia valve represents Edwards’ latest product offering advanced Resilia (bovine pericardial) tissue with an anti-calcification technology allowing devices to be stored under dry packaging conditions for improved ease of use.

Edwards has studied Resilia in two pre-market clinical trials, combining outcomes for a total of 904 patients and more than 3,800 patient years of follow-up that support the tissue replacement platform.

Aidoc’s AI-powered X-ray system cleared to detect collapsed lungs

An x-ray showing pneumothorax [Image courtesy of Aidoc]Aidoc said today it has received FDA 510(k) clearance for AI-powered X-ray detection of pneumothorax, also known as a collapsed lung.

It’s the latest indication for New York-based Aidoc’s triage and notification system, which has already been FDA 510(k) cleared for flagging suspected intracranial hemorrhage, large vessel occlusions, acute cervical spine fractures, pulmonary embolism, incidental pulmonary embolism, intra-abdominal free gas and rib fractures.

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Aidoc’s AI-powered X-ray system cleared to detect collapsed lungs

An x-ray showing pneumothorax [Image courtesy of Aidoc]

Aidoc said today it has received FDA 510(k) clearance for AI-powered X-ray detection of pneumothorax, also known as a collapsed lung.

It’s the latest indication for New York-based Aidoc’s triage and notification system, which has already been FDA 510(k) cleared for flagging suspected intracranial hemorrhage, large vessel occlusions, acute cervical spine fractures, pulmonary embolism, incidental pulmonary embolism, intra-abdominal free gas and rib fractures.

The new offering runs on all X-ray machines (including portable devices) to automatically flag suspected cases of pneumothorax so radiologists and other doctors can act before respiratory or cardiac failure.

“This FDA clearance further validates the breadth of our AI platform, going beyond specific AI algorithms to act as a healthcare AI hub for the enterprise’s cro…

Synchron says study shows safety of its brain-computer interface implant

Synchron’s Stentrode device expands inside a blood vessel on the brain to relay motor signals [Illustration courtesy of Synchron]

Four ALS patients with a Synchron Stentrode brain implant had no serious adverse events one year after their procedure, which allowed the paralyzed patients to control a computer for online shopping, banking and text communication without using their hands or voice for input.

New York-based Synchron said the study — allowed by the FDA under an Investigational Device Exemption — demonstrated the safety of its brain-computer interface (BCI) technology. The device is delivered by catheter rather than the open-brain surgeries used by other neurotech developers like Elon Musk’s Neuralink.

Synchron uses the catheter to feed the Stentrode device through a patient’s vein to the blood vessels on the brain (the YouTube video below from 2021 shows the process). Then, th…

CartiHeal wins FDA premarket approval for its Agili-C knee implant

[Image from CartiHeal]CartiHeal announced today that it received FDA premarket approval for its Agili-C implant for treating knee joint surface lesions.

Kfar Saba, Israel-based CartiHeal designed its Agili-C implant as a proprietary implant for treating cartilage lesions in arthritic and non-arthritic joints. Its PMA indication covers the treatment of an International Cartilage Repair Society (ICRS) grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).

The platform received FDA breakthrough device designation in October 2020.

According to a news release, PMA approval arrived on the back of results from a two-year investigational device exemption (IDE) pivotal clinical study confirming the superiority of Agili-C compared to microfracture and debridement, the current standard of care.

“The 2-year study results, which demonstrated superiority of the Agil…

Novo Nordisk wins FDA approval for higher-dose Ozempic for adults with type 2 diabetes

FDA has approved a 2 mg injectable dose of Novo Nordisk’s (NYSE:NVO) Ozempic (semaglutide), a once-weekly glucagon-like peptide-1 (GLP-1) analog. The indication covers improving blood sugar control and reducing the risk of cardiovascular complications in adults with type 2 diabetes when used in conjunction with diet and exercise changes.

To win the new indication, the Bagsværd, Denmark–based company provided data showing the 2 mg dose led to an average 2.1% blood glucose reduction and weight loss in adults with type 2 diabetes.

In the SUSTAIN Phase 3 clinical trial, a 1 mg dose of Ozempic helped up to 73% of people with type 2 diabetes reach the American Diabetes Association target of <7%.

Ozempic image courtesy of Novo Nordisk

The 2 mg dose could help individuals who need additional glycemic control.

“With its proven safety and efficacy, Ozempic helps deliver on blood glucose control…

FDA proposes new cybersecurity, supply chain and inspection laws for medical device manufacturers

Ventilators were in high demand during the first peaks of the COVID-19 pandemic. (Image from Raumedic)

The FDA today offered a slate of proposed laws for Congress to consider along with the agency’s $8.4 billion budget request for fiscal year 2023.

The legislative wish list includes several proposals that would affect medical device developers, manufacturers and distributors, including cybersecurity requirements for medical devices, mandatory supply chain reporting, remote inspections for FDA-regulated facilities and the destruction of dangerous imports.

Medical device cybersecurity

One proposal would require medical device manufacturers to design cybersecurity into their devices, such as the ability to update and patch software in a timely manner. Manufacturers would also need to provide cybersecurity assurance in premarket submissions, include a Software bill of Materials that tells patients …

FDA’s $8.4B budget request includes supply chain, pandemic prep and cancer funding

A lab worker at a COVID-19 diagnostic facility [Photo courtesy of Amazon]The FDA today said it wants a $2.1 billion funding bump as it released details of its $8.4 billion budget request for fiscal year 2023, which starts Oct. 1, 2022.

The budget request includes full funding of the agency’s fiscal 2022 budget request, plus new programs and initiatives that would affect medical device developers and manufacturers.

The FDA also offered complimentary legislative proposals such as cybersecurity requirements for medical device manufacturers, remote inspections and supply chain shortage reporting.

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