FDA Archives - Page 77 of 103 - Medical Design Sourcing

FDA, CDC lift pause on J&J COVID-19 vaccine

The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern.

On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the U.S., six recipients experienced cases of a rare and severe type of blood clot. Of those blood clot cases, one death was recorded.

Following a safety review that included two meetings of the CDC’s Advisory Committee on Immunization Practices, the pause was lifted on Friday, April 23, according to a news release Medical and scientific teams at the FDA and CDC examined available data to evaluate the risk of the form of blood clot known as cerebral venous sinus thrombosis (CVST) that was seen in combination with low levels of blood platelets (thrombocytopenia).

The two agencies concluded that use of the vaccine can resume…

Neurolutions wins breakthrough nod for stroke rehab device

The FDA announced today that it authorized the Neurolutions IpsiHand upper extremity rehabilitation system for stroke rehab.

Approval encompasses patients 18 years of age and older who are undergoing stroke rehabilitation to facilitate muscle re-education and need to maintain or increase their range of motion, according to a news release. It is a brain-computer-interface (BCI) device that assists in rehabilitation for stroke patients with upper extremity or hand, wrist and arm disability.

IpsiHand uses non-invasive electroencephalography (EEG) electrodes — instead of an implanted electrode or other invasive feature — to record brain activity. EEG data is then wirelessly transmitted to a tablet for analysis of the intended motor function and the signal is sent to a wireless electronic hand brace designed to move the patient’s hand.

The aim of the device is to help stroke patients improve grasping with their hands. It is currently prescription-only a…

FDA says Cordis carotid artery stent recall is serious

The FDA has classified Cordis‘ recall of its Precise Pro Rx carotid system as Class I, the most serious kind of recall.

Cordis in February recalled certain lots of its Precise Pro RX carotid stent systems because of a risk of separation of the atraumatic distal tip of the sheathed delivery system in patients.

The Precise Pro Rx is used to treat patients with narrowed carotid arteries and includes a metal (nitinol) self-expanding stent that is preloaded on a delivery catheter used to place the stent.

According to an FDA release, if the device separates during use, it may cause serious adverse events, such as the removal of the separated tip from the carotid artery, embolization distally or stroke.

To date, there have been seven complaints about the issue with the Precise Pro Rx carotid stent system. Five injuries were reported, although no deaths have been registered as a result of the issue to date.

Affected products were manufactured…

Debate series considers the promise and pitfalls of psychedelics

Photo by Sergey Katyshkin from Pexels

Intelligence Squared, the organizers of a popular debate series, recently asked a panel of experts whether psychedelics should be legalized. There was considerable overlap between the factions arguing in favor and opposition of that motion, reflecting the growing interest in psychedelic compounds for therapeutic applications. But the two camps were split when it came to the best regulatory model for psychedelic drugs.

“I advocate strongly that [psychedelics] be allowed to be studied for medical research to see what their therapeutic indications are and how they can help us to understand the brain and the mind,” said Dr. Jeffrey Lieberman, the chair of Columbia University’s department, who argued against the motion.

Rick Doblin, executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), argued for a more permissive approach that would a…

FDA approves Soundbite Medical peripheral crossing system

Soundbite Medical announced that it received FDA 510(k) approval for its SoundBite crossing system-peripheral.

Montreal-based Soundbite Medical’s SoundBite crossing system-peripheral (SCS-P) with the 0.014″ active wire (14P) is a recanalization tool designed to help physicians with the placement of conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions (CTOs) in patients suffering from heavily calcified above-the-knee (ATK) and below-the-knee (BTK) peripheral artery disease (PAD), according to a news release.

The SoundBite crossing system – peripheral (14P) includes the reusable SoundBite console, a single-use sterile SoundBite active wire 14P and their respective accessories.

SCS-P uses Soundbite’s proprietary method that delivers shockwaves via guidewire platforms to selectively “micro-jackhammer” through calcified lesions.

“This approval is an important step in …

Biogen moves forward with aducanumab launch plans

Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab seemed to be a potential blockbuster until an FDA advisory committee voiced skepticism in November about the drug.

FDA reviewers had previously assessed the drug’s prospects more positively.

The company is preparing for the event of an FDA approval of the drug in June.

Biogen’s CEO Michel Vounatsos said in an analyst call today that he expects the antibody drug to sell well given the surging numbers of Alzheimer’s patients in the U.S. and elsewhere. “We anticipate if approved, there will be a large influx of patients,” Vounatsos concluded.

The company has argued that aducanumab slows disease progression in Alzheimer’s patients, which is a feat that no other FDA-approved drug can manage. But critics have argued that the company has failed to demonstrate that the drug is effective and have expressed concern over the drug’s potential to cause amyloi…

Getinge wins 3 FDA clearances for ventilators

Getinge announced today that it received FDA 510(k) clearance for three products to expand its Servo platform of ventilators.

Gothenburg, Sweden-based Getinge’s latest clearances are for new software options for the Servo-u and Servo-n ventilators, as well as clearance for use of the new Servo-u MR ventilator in the MRI room, according to a news release. The three newly cleared products are expected to be made available in the U.S. in July 2021.

Get the full story at our sister site, Medical Design & Outsourcing.

Getinge wins 3 FDA clearances for ventilators

Getinge announced today that it received FDA 510(k) clearance for three products to expand its Servo platform of ventilators.

Gothenburg, Sweden-based Getinge’s latest clearances are for new software options for the Servo-u and Servo-n ventilators, as well as clearance for use of the new Servo-u MR ventilator in the MRI room, according to a news release. The three newly cleared products are expected to be made available in the U.S. in July 2021.

The software upgrades for Servo-u and Servo-n include the automatic stepwise recruitment maneuver, a standardized and automated workflow designed to guide lung recruitment and help clinicians identify a personalized PEEP that provides the lowest driving pressure.

Additionally, the upgrades offer stress index and transpulmonary pressure monitoring, including key parameters for the assessment of lung stress during controlled and spontaneous ventilation, which compliments the lung-protective toolkit that divid…

FDA loses ‘drug or device’ argument again

Drug or device? Genus Medical Technologies says it’s a device. (Image from Genus Medical Technologies)

A federal appeals court has ruled that the FDA must regulate a barium sulfate product ingested before imaging as a device rather than a drug.

The decision counts as a win for Genus Medical Technologies (St. Louis), maker of the Vanilla SilQ line of contrast agents used to image structures or fluids within the body.

Genus has manufactured Vanilla SilQ since 2015 and sought regulation for it as a device because the opacity of its barium sulfate component enables healthcare providers to visualize the gastrointestinal tract. Barium sulfate is an inert metal salt that does not chemically interact with human cells or tissue, as a drug does.

Get the full story on our sister site, Medical Design & Outsourcing.

Novo Nordisk to test oral semaglutide as an obesity therapy

Global pharma firm Novo Nordisk (NYSE:NVO) will launch a Phase 3a study to investigate the potential of oral Ozempic (semaglutide) to treat obesity.

The drug is currently indicated in a subcutaneous form in the U.S. for people with type 2 diabetes to improve glycemic control in conjunction with diet and exercise and to lower diabetics’ risk of major adverse cardiovascular events.

The most recent Phase 3a trial will test an oral 50-mg dose of the drug with roughly 1,000 volunteers who are obese or overweight with comorbidities.

The company anticipates that the 68-week study will kick off in the second half of 2021.

Recent clinical trial results indicate that subcutaneous semaglutide paired with behavioral therapy can support weight loss.

Novo Nordisk has also filed a new drug application with the FDA for a 2.4-mg dose of subcutaneous semaglutide for chronic weight management. The company is seeking a similar indication in the European m…

FDA releases scathing inspection report regarding Emergent BioSolutions plant

An FDA report cites multiple failures in an Emergent BioSolutions plant tapped to produce vaccines for Johnson & Johnson and AstraZeneca.

The vaccine plant had been forced to discard up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine in a single manufacturing batch.

Emergent Biosolutions recently paused production of the vaccine during the FDA inspection and had quarantined doses it had in reserve. The FDA will subject those vaccines to further testing before clearing the way for their distribution, explained two head FDA officials, Peter Marks and Janet Woodcock, in a statement.

Get the full story from our sister site, Pharmaceutical Processing World.

FDA approves Medtronic’s next-gen Pipeline Flex device with anti-clotting tech

Medtronic (NYSE:MDT) announced today that it received FDA approval for its Pipeline Flex embolization device with Shield Technology.

Fridley, Minn.–based Medtronic’s Shield Technology is a proprietary platform designed to advance flow diversion therapy through a surface-modified implant device that demonstrates a reduction in material thrombogenicity — a reduction in the tendency of the surface treatment material to create clots — according to a news release.

New York City-based NYU Langone Health performed the first patient procedure in the U.S. with the newly cleared Pipeline Flex device with Shield Technology.

Pipeline Flex, which has been on the market for close to 10 years in the U.S., is a device designed to divert blood flow away from a brain aneurysm. A braided, cylindrical mesh tube is implanted across the base or neck of the aneurysm. It interrupts blood flow into the aneurysm and reconstructs the diseased section of the parent vessel. Read more