FDA Archives - Page 55 of 103 - Medical Design Sourcing

FDA clears HeartVista’s MRI automation platform for Siemens Healthineers scanners

HeartVista announced today that it received FDA 510(k) clearance for its artificial intelligence-assisted One Click MRI acquisition software.

Palo Alto, California-based HeartVista’s One Click MRI software received the FD clearance for delivery on Siemens Healthineers’ MRI scanners. The company said in a news release that its AI-assisted solutions make cardiac magnetic resonance (CMR) exams on Siemens’ MRI scanners simpler, faster and capable of delivering more consistent results.

The company said its One Click MRI software includes product-wide speed and scan accuracy enhancements, along with new real-time automated analysis of regional wall motion as part of cardiac function assessment.

Additionally, the platform includes new registration of perfusion images for easier visual defect detection, enhanced T1-mapping for cardiomyopathy analysis and dedicated septal T1-mapping for myocarditis.

HeartVista initially won FDA 51…

Pfizer and BioNTech file for FDA authorization of COVID-19 vaccine boosters for all adults

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have filed paperwork with FDA to authorize their COVID-19 vaccine for all adults 18 and older.

The two companies had filed a supplemental Biologics License Application for a booster dose of the COVID-19 vaccine in adults at least 16 years old.

FDA did not accept the supplemental Biologics License Application, however. Instead, FDA amended the EUA for the Pfizer-BioNTech COVID-19 vaccine in September to allow individuals with an elevated risk to receive a single booster dose. The EUA required that eligible individuals receive a booster dose at least six months after completing the primary series.

Earlier, an advisory committee had decided there was insufficient evidence to warrant approval for all adults. In particular, the committee expressed concerns about the rare risk of myocarditis in some younger vaccine recipients.

Instead, the U.S. authorized Pfizer booster doses in October for adults 6…

Moderna pursues EU authorization of its COVID-19 vaccine in children aged 6 to 11

Moderna (NSDQ: MRNA) has filed paperwork to permit the evaluation of two 50-µg doses of its Spikevax (mRNA-1273) vaccine in children ages 6-11 years in the European Union.

Moderna has filed paperwork to permit the evaluation of its Spikevax vaccine in children ages 6–11 years in the European Union.

Last week, the company announced that FDA had delayed its review of the mRNA-1273 vaccine in 12- to 17-year-olds to investigate reports of myocarditis apparently linked to the vaccine.

EU regulatory authorities have not yet authorized a COVID-19 vaccine for children younger than 12. The Austrian capital of Vienna, however, will begin vaccinating young children against the novel coronavirus on November 12.

Cambridge, Massachusetts–based Moderna has an ongoing Phase 2 trial, dubbed “KidCOVE,” investigating the use of its vaccine in children as young as 6 months of age.

The company reports that vaccine efficacy — measured as protection against sympt…

Vicarious Surgical details its regulatory plans with FDA

[Image courtesy of Vicarious Surgical]Vicarious Surgical (NYSE:RBOT) announced in its quarterly earnings report that it set its FDA regulatory process in motion with a pre-submission.

CEO Adam Sachs said in a news release that the robotic surgery technology developer, which just completed its first quarter as a publicly-traded company, filed a “detailed regulatory plan” in the form of a pre-submission to the FDA as it looks to move toward 510(k) approval for its robotic surgical platform.

“This quarter marks our entry into the public markets, and I am incredibly proud of our teams and employees for their contributions to our company’s growth to date,” Sachs said in the release. “We are well-positioned to continue development of our next generation robotics system and are also pleased to announce that we have just filed a detailed regulatory plan in the form of a pre-submission to the FDA. We remain committed to transforming outcomes for sur…

Harnessing the power of real-world data requires careful consideration

Image courtesy of Pixabay

The use of real-world data (RWD) has boomed during the pandemic, but the pharmaceutical industry has only scratched the surface in terms of tapping its potential.

The use of such data, however, is set to grow, given the FDA’s recent release of new guidance concerning the use of electronic health records and medical claims data for regulatory decision-making for drugs and biologics.

Two years ago, some people in the industry questioned “whether RWD would have any application in the world of clinical development,” said Jeff Elton, CEO of ConcertAI. Those days are over. It is now clear that RWD is important, given the FDA guidance and the surge in use in RWD during the pandemic.

The level of rigor concerning RWD is set to grow, given FDA’s feedback concerning the use of such data in clinical trial designs, trial interpretation. “The expectati…

Senators urge CMS to create payment program for breakthrough devices

Ten U.S. senators are calling on the U.S. Centers for Medicare & Medicaid Services (CMS) to create a new rule allowing government payments for medical devices designated as breakthroughs by the FDA.

CMS said in September that it would not move forward with the Medicare Coverage for Innovative Technologies (MCIT) rule, citing safety concerns for Medicare patients.

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

Senators urge CMS to create payment program for breakthrough devices

Ten U.S. senators are calling on the U.S. Centers for Medicare & Medicaid Services (CMS) to create a new rule allowing government payments for medical devices designated as breakthroughs by the FDA.

CMS said in September that it would not move forward with the Medicare Coverage for Innovative Technologies (MCIT) rule, citing safety concerns for Medicare patients.

In a Nov. 5 letter, the bipartisan group of lawmakers — U.S. Sens. Michael Bennet, John Barrasso, Marsha Blackburn Bill Cassidy, Maggie Hassan, Mark Kelly, Ben Sasse, Jeanne Shaheen, Kyrsten Sinema and Todd Young — urged CMS Administrator Chiquita Brooks-LaSure to propose a new rule.

“We understand that CMS proposed repealing the existing rule after experts raised concerns about operationalization and patient benefit during the comment process,” the letter read. “CMS should address these concerns and move forward with a pathway for coverage that allows for collection of ap…

FDA clears AFib notification on Apple Watch

An FDA letter confirms that Apple (NSDQ:AAPL) received 510(k) clearance for an irregular heart rhythm notification on the Apple Watch.

The letter, dated Oct. 22, stated that, after reviewing Apple’s 510(k) premarket notification of intent to market the device, the FDA determined that the device is substantially equivalent to legally marketed predicate devices for the indications Apple sought.

Get the full story at our sister site, MassDevice.

FDA clears AFib notification on Apple Watch

An FDA letter confirms that Apple (NSDQ:AAPL) received 510(k) clearance for an irregular heart rhythm notification on the Apple Watch.

The letter, dated Oct. 22, stated that, after reviewing Apple’s 510(k) premarket notification of intent to market the device, the FDA determined that the device is substantially equivalent to legally marketed predicate devices for the indications Apple sought.

Apple designed its “Irregular Rhythm Notification Feature 2.0” (IRNF 2.0) to be comprised of two mobile medical apps — one on Apple Watch and one on the iPhone — that are intended to analyze pulse rate data collected by the watch’s PPG sensor to identify episodes of irregular heart rhythms consistent with AFib and provide a notification to the user.

The background screening tool uses the PPG sensor on the Apple Watch Series 3, Series 4, Series 5 and SE. There is no way for a user to initiate analysis of pulse rate data.

If the irregula…

FDA clears XO Cross microcatheters

Transit Scientific this week announced that it has received FDA clearance for its hydrophilic-coated XO Cross microcatheters for guidewire support, exchange and contrast media injection in the peripheral vasculature.

The 510(k) clearance includes new 2Fr XO Cross 14 microcatheters, 2.6Fr XO Cross 18 microcatheters and 3.8Fr XO Cross 35 support catheters. They can be used with standard 0.014 in., 0.018 in. and 0.035 in. guidewires in 90 cm, 135 cm, 150 cm and 175 cm working lengths.

Park City, Utah-based Transit Scientific designed the XO Cross platform with a metal-alloy exoskeleton, non-tapered shaft, and proprietary hydrophilic lubricious coating. It is designed for use in peripheral lesions but not limited to above-the-knee and below-the-knee CTOs from contralateral femoral, antegrade femoral and retrograde pedal access.

Get the full story on our sister site, Medical Tubing + Extrusion.

Abbott pledges funding to increase clinical trial diversity

A researcher at the Morehouse School of Medicine [Photo courtesy of Morehouse School of Medicine]Abbott Laboratories (NYSE:ABT) today announced $5 million in scholarships to promote diversity in the next generation of clinical trial leaders as part of an initiative to improve healthcare for all.

The Abbott Park, Illinois-based developer and manufacturer of medical devices and drugs said its initiative also includes forming the Diversity in Research Medical Advisory Board, funding improved access for women and under-represented communities in Abbott trials, and convening patient advocates, industry experts, trialists and physicians to develop and share ways to increase clinical trial diversity.

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

Abbott pledges funding to increase clinical trial diversity

A researcher at the Morehouse School of Medicine [Photo courtesy of Morehouse School of Medicine]

Abbott Laboratories (NYSE:ABT) today announced $5 million in scholarships to promote diversity in the next generation of clinical trial leaders as part of an initiative to improve health care for all.

The Abbott Park, Illinois-based developer and manufacturer of medical devices and drugs said its initiative also includes forming the Diversity in Research Medical Advisory Board, funding improved access for women and under-represented communities in Abbott trials, and convening patient advocates, industry experts, trialists and physicians to develop and share ways to increase clinical trial diversity.

The FDA has encouraged more gender and ethnic/cultural diversity in clinical trials to improve the safety and efficacy of medical products for all who will use them, but factors like trust, site access and commun…