FDA Archives - Page 31 of 103 - Medical Design Sourcing

FDA clears Neuronetics’ therapy for anxious depression

[Image from Neuronetics]Neuronetics (Nasdaq:STIM) announced today that the FDA cleared a new indication for its transcranial magnetic stimulation (TMS) system.

The new indication for the NeuroStar advanced therapy for mental health allows the system to treat anxiety symptoms for adult patients who suffer from major depressive disorder (MDD), also known as anxious depression.

NeuroStar is a non-drug, non-invasive treatment that can improve the quality of life for people suffering from neuro health conditions when traditional medication hasn’t helped.

Malvern, Pennsylvania-based Neuronetics said in a news release that the FDA accepted its use of real-world data analyzed from its proprietary TrakStar platform, with that database containing digital data from patients treated with NeuroStar at over 1,000 centers, providing a large sample from a diverse patient group treated in a clinical practice setting.

“Today, we celebrate a big win for NeuroStar patie…

FDA clears Medtronic’s next-gen UNiD spine analyzer

Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its UNiD spine analyzer v4.0 planning platform.

The UNiD spine analyzer v4.0 includes a new Degen algorithm for degenerative spine procedures, with the algorithm designed to leverage machine learning to help surgeons plan and personalize procedures for patients undergoing lower lumbar spine surgery and predicts spinal compensation mechanisms six months after the operation.

According to a news release, the new update includes enhancements to the pediatric and adult deformity algorithms predicting compensatory changes to the spine. The company said it is the first and only company with FDA-cleared predictive models for spine surgery.

Medtronic’s release comes with a new UNiD hub patient-centric platform that enables surgeons to track patients throughout the perioperative care pathway and assess surgical results through long-term radiographic and patient-reported outcomes d…

FDA warns four companies over selling honey tainted with erectile dysfunction drugs

FDA has sent warning letters to four companies for illegally marketing honey-based products with unlisted active drug ingredients found in the erectile dysfunction drugs Cialis (tadalafil) and Viagra (sildenafil).

The agency confirmed the presence of contaminants in the products through laboratory testing.

The agency sent the warning letters to the following companies:

Thirstyrun LLC (also known as US Royal Honey LLC). MKS Enterprise LLC. Shopaax.com. 1am USA Incorporated dba Pleasure Products USA.

FDA warned of similarly tainted products in April.

The FDA has asked the above companies to provide responses within 15 working days and a plan for how they will remedy the issue. Companies that fail to satisfy the FDA’s concerns quickly may face legal action, including product seizure or injunction.

In February, the agency released an advisory that several herbal supplements sold on Amazon were tainted with tadalafil and sildenafil, which ar…

FDA clears Eko’s AI for detecting heart disease

[Image from Eko]Eko announced today that it received FDA clearance for its Eko Murmur Analysis Software (EMAS) for adult and pediatric patients.

The next generation of Eko’s murmur detection capabilities, EMAS represents the first and only smart stethoscope on the market that can identify and differentiate between innocent and structural heart murmurs indicative of valvular heart disease.

According to a news release, Eko has transformed the traditional stethoscope into an objective, low-cost and scalable screening tool that can identify significant structural heart disease within seconds on the front lines of care. The company has collaborated in with 3M to connect its software and artificial intelligence algorithms and help clinicians use 3M’s stethoscope to better interpret sounds and detect heart murmurs, too.

“This latest FDA clearance is another way in which Eko is improving access to better heart health through clinically-validated algorit…

Abbott wins breakthrough nod for deep brain stimulation for managing severe depression

Abbott (NYSE:ABT) announced today that it received FDA breakthrough device designation for its deep brain stimulation (DBS) system.

The breakthrough nod allows Abbott to investigate the use of its DBS system in treatment-resistant depression (TRD), a form of major depressive disorder (MDD).

Abbott Park, Illinois-based Abbott designed its DBS system as a personalized, adjustable therapy that involves implanting thin wires (leads) into targeted areas of the brain. A pulse generator implanted under the skin in the chest is connected to the leads and produces electrical impulses that can modulate abnormal brain activity.

The company said in a news release that, while its DBS system has traditionally been used to help control symptoms for people with movement disorders, including Parkinson’s disease and essential tremor, evidence suggests that implanting electrodes in the part of the brain that regulates mood could help reduce symptoms of TRD.

Ab…

Ancora Heart’s AccuCinch ventricular restoration system wins FDA breakthrough nod

[Image from Ancora Heart]Ancora Heart announced today that it received FDA breakthrough device designation for its AccuCinch ventricular restoration system.

Santa Clara, California-based Ancora Heart designed its AccuCinch system to provide a minimally invasive treatment option for patients who have symptomatic heart failure (HF) with reduced ejection fraction (HFrEF). The company is currently evaluating the system in the Corcinch-HF pivotal clinical trial.

According to a news release, as the only completely transcatheter procedure for treating the enlarged left ventricle, AccuCinch offers a fundamentally different and innovative device-based therapy for improving the structure and function of the heart, helping to bring relief to HF patients who remain symptomatic despite current guideline-directed medical care.

“The chronic and progressive nature of heart failure leaves many patients to face an increasingly challenging future as existing treatments, inclu…

July 2022 Issue: Pulsed-field ablation, DeviceTalks Boston and the Pharma 50

What is pulsed-field ablation? Here’s what you need to know

Dexcom CEO expects ‘science boom’ with CGM, automated insulin delivery

Tips for vetting contract manufacturers

They said it at DeviceTalks Boston

FDA can’t explain drop in device recalls, but experts point to COVID disruption

2022 Pharma 50: The 50 largest pharmaceutical companies

Innovators shake up the Pharma 50

As a father raising a toddler and an infant, I was relieved by the latest milestone in the COVID-19 pandemic: the authorization of vaccines for children between 6 months and 5 years.

The good news came as Pharma Editor Brian Buntz and the rest of our team were putting the final touches on this edition’s Pharma 50 project. It’s our annual ranking of the biggest pharmaceutical companies by global revenue, featured on our affiliated Drug Discovery & Development site. (Our Big 100 report on largest medic…

FDA can’t explain drop in device recalls, but experts point to COVID disruptions

The FDA acknowledged interruptions with notifications from recalling firms during the pandemic, while regulatory experts point to fewer inspections and fewer procedures.

FDA medical device product recalls dropped last year to their lowest level since 2013, according to a Medical Design & Outsourcing analysis of recall data from the regulatory agency.

Medtech regulatory experts said the COVID-19 pandemic showed room for improvement in FDA oversight and postmarket surveillance of medical devices.

Device products recalled in fiscal year 2021 (ended Sept. 30, 2021) totaled 2,607, a 14.3% decrease from the 3,042 recalls reported in fiscal 2020.

The drop in device recalls occurred at the same time the FDA put more emphasis on fighting the COVID-19 pandemic and improving device safety protocols, according to FDA’s Center for Devices and Radiological Health (CDRH) annual report. CDRH Director Dr. Jeff Shuren said in September that the agency was “star…

Pfizer and BioNTech forge new COVID-19 vaccine deal with U.S. government

Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (Nasdaq:BNTX) profited handsomely from COVID-19 vaccine sales in 2021. The firms raked in more than $59 billion in combined sales of the Comirnaty vaccine.

The two companies have now announced a new vaccine supply agreement with the U.S. government worth $3.2 billion. Under the terms of the agreement, the government will receive 105 million additional doses of the vaccine at the 30 µg, 10 µg and 3 µg dose levels.

The deal could include an omicron-adapted COVID-19 vaccine, assuming FDA authorizes an updated booster.

Yesterday, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to back the use of omicron-containing boosters.

Pfizer announced that it could begin shipping doses for the deal as soon as the late summer and continue into the fourth quarter of 2022.

The U.S. government also has the option to buy up to 195 million additional doses for a total of 300…

Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials

Blackrock Neurotech’s Utah array is used in its brain-computer interface implant to sense brain signals. [Photo courtesy of Blackrock]Blackrock Neurotech and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL) are working together on the first portable brain-computer interface (BCI) to allow patients to participate in research trials from home.

A Blackrock representative said it’s the final step as the company prepares to launch its first commercial product early next year.

Salt Lake City-based Blackrock plans to submit its first commercial BCI device, called MoveAgain, to the FDA this year.

Blackrock wants its BCI platform to be the first one that’s commercially available to people with paralysis. Its implant has been used in patients since 2004 through research studies, with zero FDA-reported serious adverse events since then.

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

Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials

Blackrock Neurotech’s Utah array is used in its brain-computer interface implant to sense brain signals [Photo courtesy of Blackrock]

Blackrock Neurotech and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL) are working together on the first portable brain-computer interface (BCI) to allow patients to participate in research trials from home.

A Blackrock representative said it’s the final step as the company prepares to launch its first commercial product early next year.

Salt Lake City-based Blackrock plans to submit its first commercial BCI device, called MoveAgain, to the FDA this year.

Blackrock wants its BCI platform to be the first one that’s commercially available to people with paralysis. Its implant has been used in patients since 2004 through research studies, with zero FDA-reported serious adverse events since then.

“Through this expansion…

How Cybin aims to maximize the potential of two classical psychedelics

Classical psychedelics can be agents of chaos. In sufficient doses, they can trigger experiences of ego death or dissolution, as researchers have noted since the 1960s. Psychedelics can also help promote neural plasticity and uproot negative patterns to treat challenging-to-treat mental health disorders. FDA has acknowledged the potential of psilocybin for mental health by twice granting Breakthrough Therapy Designation status to the compound as a potential therapy for serious depression.

The startup Cybin (Toronto, Canada) aims to harness the therapeutic potential of psychedelics while minimizing possible adverse side effects.

Cybin’s deuterated psilocybin analog CYB003 could treat major depressive disorder (MDD) and alcohol use disorder (AUD) while potentially being better tolerated than traditional psilocybin.

CYB003 is the company’s first focus as psilocybin is the most studied psychedelic molecule in academic studies “with decad…