FDA Archives - Page 51 of 103 - Medical Design Sourcing

OrganOx wins FDA PMA for its normothermic machine perfusion device

[Image from OrganOx]OrganOx announced today that it received FDA premarket approval (PMA) for its metra normothermic machine perfusion (NMP) system.

Oxford, England-based OrganOx designed its metra system as a fully automated NMP device for the preservation and transport of donor livers set for transplantation. The transportable device sustains donor livers in a functioning state for up to 12 hours, mimicking the environment of the human body with warm, oxygenated blood and nutrients between donation and transplantation.

The metra device can be used for liver grafts from donors less than or at 40 years old with less than or equal to 20 minutes of functional warm ischemic time. Liver grafts must come from donors with macrosteatosis at or below 15% in a near-physiologic, normothermic and functioning state.

According to a news release, premarket approval from the FDA includes both livers from donors after brain death (DBD) and livers from donors after circulat…

FDA approves Edwards Lifesciences Sapien 3 with Alterra for pulmonary regurgitation

Edwards’ Sapien 3 transcatheter heart valve (Image from Edwards Lifesciences)

Edwards Lifesciences (NYSE:EW) announced today that it received FDA approval for the use of its Sapien 3 transcatheter valve with the Alterra adaptive prestent.

Irvine, California-based Edwards garnered the FDA nod for use of the Sapien 3 with Alterra for patients with severe pulmonary regurgitation.

The Sapien 3 transcatheter pulmonary valve (TPV) system combines the Sapien 3 valve and the Alterra adaptive present to expand transcatheter therapy options for congenital heart valve disease patients, Edwards said in a news release. The company designed Alterra to compensate for variations in size and morphology of the right ventricular outflow tract to provide a stable landing zone for the Sapien 3 valve.

Indication for the Edwards Sapien 3 TPV system with Alterra covers the management of pediatric and adult patients with severe pulmonary regurgitation as measured by echoca…

FDA authorizes abortion drug distribution by mail

The FDA has decided to allow dispensing of mifepristone from Danco Laboratories by mail using certified prescribers of pharmacies. The move also allows dispensing of the drug via telemedicine.

The agency had previously required that individuals obtain the abortion drug mifepristone (Mifeprex) in person.

FDA notes that the mail-order distribution model became popular during the pandemic, leading the agency to cease enforcing the in-person dispensing rule.

Some states, however, have moved to block the distribution of the drug, which is also known as RU486.

FDA indicates that the progestin antagonist mifepristone be used together with the drug misoprostol in the first 70 days of gestation. Misoprostol is a widely available prescription drug indicated as an ulcer treatment. FDA recommends that patients take mifepristone first and then misoprostol two days later.

Nearly half of U.S. states have either banned or limited the use of the mifepriston…

Wells Fargo downgrades Medtronic stock

According to reports, Wells Fargo downgraded Medtronic’s (NYSE:MDT) stock after the company received an FDA warning letter.

Yesterday, the company confirmed that it received an FDA warning letter after an inspection of its Diabetes Business, with the regulatory body reporting inadequacy of specific medical device quality system requirements at the Northridge, California, facility, with the areas of risk assessment, corrective and preventive action, complaint handling, device recalls and the reporting of adverse events all under scrutiny.

Shares of MDT closed yesterday down 6% in total at $104.94 per share on the back of the news around the FDA warning letter.

SeekingAlpha reported today that Wells Fargo had upgraded Medtronic to “Overweight” in June after determining that growth would pick up on the back of the company’s pipeline, but today downgraded the stock to “Equal Weight” following setbacks within that pipeline,…

FDA grants breakthrough nod to Fist Assist Devices’ vein dilation system

Fist Assist Devices announced today that it received FDA breakthrough device designation for the Fist Assist model FA-1 device.

Las Vegas-based Fist Assist touts its FA-1 device as the world’s first wearable for pre-surgical vein dilation that promotes AV fistula creation in adult patients diagnosed with chronic renal failure whose pre-operative assessment of the venous anatomy suggests that superficial arm vein or perforator vein size is inadequate for the creation of an AV fistula for hemodialysis.

According to a news release, the company designed the Fist Assist model FA-1 to be an intermittent pneumatic compression device worn on the arm to promote vein dilation. The automated device compresses the outflow vein and, according to Fist Assist, significantly improves patient compliance compared to other vein dilation alternatives.

Fist Assist Founder & CEO Dr. Tej Singh said in the release that recently published data from the FACT trial on st…

FDA approves Bristol Myers Squibb drug to prevent graft versus host disease

The FDA today approved Bristol Myers Squibb’s Orencia (abatacept) for the prophylaxis (prevention) of acute graft versus host disease (aGVHD).

According to an FDA release, this is the first FDA drug approval for aGVHD prevention, incorporating real-world evidence as a component of the determination of clinical effectiveness.

Orencia — originally approved by the FDA in 2005 for treating adult rheumatoid arthritis and also approved for treating polyarticular juvenile idiopathic arthritis and adult psoriatic arthritis — may now be used in adults and pediatric patients two years of age or older undergoing hematopoietic stem cell transplantation (commonly known as bone marrow transplantation or stem cell transplantation) from an unrelated donor.

Bristol Myers Squibb had previously received breakthrough, orphan drug and priority review designations with the development of the product partially supported by the FDA’s Orphan Products Grants Program.<…

Intuitive wins FDA clearance for robotic stapler

Intuitive (NSDQ:ISRG) announced today that it received FDA clearance for its SureForm stapler and reloads for use in surgery.

Sunnyvale, California-based Intuitive designed its fully wristed, 8 mm SureForm 30 curved-tip stapler and reloads (gray, white and blue) for use in general, thoracic, gynecologic, urologic and pediatric surgery.

Its aim is to help surgeons better visualize and reach anatomy through a combination of the 8 mm diameter instrument shaft and jaws, 120-degree cone of wristed articulation and the curved tip. As the stapler fits through the 8 mm da Vinci surgical robot instrument cannula, it allows different angles for surgeons to approach patient anatomy.

The 8mm SureForm 30 curved-tip stapler also integrates SmartFire software for optimizing staple line performance by measuring tissue compression before and during stapling.

According to a news release, the company expects to launch the 8 mm SureForm 30 stapler in the U.S. in 2022…

Medtronic Diabetes receives FDA warning over quality system requirement inadequacies

Medtronic (NYSE:MDT) announced today that it received an FDA warning letter after an inspection of its Diabetes Business.

The company received the letter on Dec. 9 for its Northridge, California facility — the Medtronic Diabetes Business headquarters — following an inspection that concluded in July 2021.

Shares of MDT were down 6.3% at $104.62 per share in early-morning trading today on the back of the news of the FDA letter.

Get the full story at our sister site, Drug Delivery Business News.

A future beyond distance: How remote collaboration technologies are changing how we work

Image courtesy of Avatour

Site meetings are an integral part of business for life sciences companies — whether supplier audits, internal quality assurance inspections, process reviews, or FDA inspections. Often, these site visits involve traveling long distances to bring auditors, experts, or global teams together. Pre-COVID, the pharmaceutical and biotechnology industries spent enormous budgets on travel costs.

Direct expenses aren’t the only cost of these meetings. Those who travel for site visits incur a significant overhead of productive time lost in airports and hotels. On-site safety, security and cleanliness protocols are time-consuming and disruptive, often requiring the interruption of production for days at a time. And every outside individual brought into a lab or production facility creates some amount of risk.

Until now, life sciences companies have accepted these costs because there were…

A future beyond distance: How remote collaboration technologies are changing how we work

Image courtesy of Avatour

Site meetings are an integral part of business for life sciences companies — whether supplier audits, internal quality assurance inspections, process reviews, or FDA inspections. Often, these site visits involve traveling long distances to bring auditors, experts, or global teams together. Pre-COVID, the pharmaceutical and biotechnology industries spent enormous budgets on travel costs.

Direct expenses aren’t the only cost of these meetings. Those who travel for site visits incur a significant overhead of productive time lost in airports and hotels. On-site safety, security and cleanliness protocols are time-consuming and disruptive, often requiring the interruption of production for days at a time. And every outside individual brought into a lab or production facility creates some amount of risk.

Until now, life sciences companies have accepted these costs because there were…

Medtronic cerebral/somatic oximetry system wins FDA clearance

[Image from Medtronic]Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its INVOS 7100 cerebral/somatic oximetry system.

INVOS 7100, which Medtronic designed to pick up key signals to inform time-critical decisions by pediatric clinicians, received clearance for children from birth through age 18. The signals it picks up are related to hemodynamic management, ventilation and resuscitation for premature infants, neonates, children and other patients treated by pediatric clinicians.

The INVOS near-infrared spectroscopy monitoring system previously garnered clearance for adult patients. The real-time measures of tissue perfusion and oxygenation provided by INVOS 7100 provide early alerts to changes in perfusion before other vital sign measurements, according to a news release.

Medtronic designed INVOS 7100 with unique algorithms for measuring acute alterations in hemodynamics, regional oxygen saturation and oxygen metabolism. The p…

FDA advisory votes against BrainsGate’s neurostim device for treating stroke

At the end of last week, an FDA advisory panel voted down BrainsGate’s neurostimulation device for treating stroke.

BrainsGate designed its technology as a five-minute procedure in which a neurostimulator implant is injected into an existing canal to stimulate a nerve center and augment collateral blood flow, improving stroke patients’ outcomes within a 24-hour window.

The platform has CE mark approval and BrainsGate initially applied for FDA premarket approval in February 2020.

Meeting on Friday, the panel voted 7-3 (with three abstentions) against the device, determining that the benefits of BrainsGate’s treatment did not outweigh the risk for patients as reasonable assurance of effectiveness was not provided, although assurance of safety was evident, according to an FDA executive summary.

A major hangup for the panel was the fact that the device changed during the course of BrainsGate’s clinical trial of more than 1,000 subjec…