FDA Archives - Page 42 of 103 - Medical Design Sourcing

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.

FDA budget request highlights for medical device developers and manufacturers include:

Pandemic preparedness

The request includes $1.6 billion in mandatory pandemic planning funding over five years, including resources for the FDA to “modernize its regulatory capacity by strengthening its …

FDA clears Ossio’s OssioFiber suture anchors for bone fixation

Ossio announced today that it received the third FDA clearance for its OssioFiber product family in recent months.

Woburn, Massachusetts-based Ossio’s latest regulatory nod covers the OssioFiber suture anchors (4.75 mm-5.5 mm) for use in the fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in a variety of specific orthopedic procedures.

According to a news release, Ossio intends to initiate the U.S. launch of the OssioFiber suture anchors sometime in the second quarter of 2022.

Today’s announcement is the most recent in a series of regulatory victories for the OssioFiber intelligent bone regeneration technology product line, with OssioFiber compression staples winning FDA clearance in January 2022 and the OssioFiber compression screws garnering the same nod in December 2021. Ossio plans to launch both product lines in the third quarter of this year.

All Ossio implants include the OssioFib…

Staar Surgical wins FDA approval for Evo Visian implantable Collamer lens

[Image from Staar Surgical]Staar Surgical (Nasdaq:STAA) announced today that it received FDA approval for its Evo/Evo+ Visian implantable Collamer lens.

Lake Forest, California-based Staar Surgical designed the Evo biocompatible implantable lens for the correction of myopia and myopia with astigmatism.

More than 1 million Evo lenses have been implanted by doctors outside the U.S. to date, according to a news release. The lens, which represents a different option to Lasik, is added to a patient’s eye through a quick surgical procedure in which there is no removal of corneal tissue. The lens can be removed by a doctor if ever desired, too.

Evo lenses are implanted within the posterior chamber of the eye directly behind the iris and in front of the natural crystalline lens. FDA indication for use in phakic eye treatment covers patients between ages 21 and 45 years old with myopia/myopic astigmatism.

“We are thrilled to make EVO available to U.S. s…

FDA clears Biobeat’s remote vital sign monitoring system

[Image from Biobeat]Biobeat announced today that it received FDA 510(k) clearance for its wearable remote patient monitoring device.

FDA clearance allows the wearable device to monitor respiratory rate and body temperature in addition to cuffless blood pressure, blood oxygen saturation and pulse rate.

Petah Tikva, Israel-based Biobeat’s wireless wrist and chest monitoring devices became the first of their kind to receive FDA clearance for cuffless blood pressure monitoring from photoplethysmography (PPG) only in 2019. The platform can support health teams by transmitting real-time patient data, according to a news release.

The system uses proprietary, non-invasive reflective PPG monitoring technology to automatically and continuously track multiple vital signs and health parameters. It connects to a cloud-based patient management system that provides real-time data and alerts.

Biobeat’s system includes an automated, customizable early war…

What you need to know about the FDA’s Total Product Life Cycle Advisory Program pilot

An FDA initiative meant to enhance medical device development is closer than ever to becoming a reality after it survived negotiations with the industry over the Medical Device User Fee Amendments (MDUFA) reauthorization.

My last post on MDUFA V touched on the FDA’s Total Product Life Cycle Advisory Program (TAP) pilot laid out in the regulatory agency’s commitment letter. Though the pilot could be modified or scrapped by the FDA after hearing from the public in April or by lawmakers as they consider reauthorizing MDUFA, the letter offers the program’s latest and most detailed outline.

“The long-term vision for a successful TPLC Advisory Program (TAP) is to help spur more rapid development as well as more rapid and widespread patient access to safe, effective, high-quality medical devices of public health importance,” the FDA said in the letter. “A mature TAP will also help ensure the sustained success of the breakthrough devices program.”

A significant …

What you need to know about the FDA’s Total Product Life Cycle Advisory Program pilot

An FDA initiative meant to enhance medical device development is closer than ever to becoming a reality after it survived negotiations with the industry over the Medical Device User Fee Amendments (MDUFA) reauthorization.

My last post on MDUFA V touched on the FDA’s Total Product Life Cycle Advisory Program (TAP) pilot laid out in the regulatory agency’s commitment letter. Though the pilot could be modified or scrapped by the FDA after hearing from the public in April or by lawmakers as they consider reauthorizing MDUFA, the letter offers the program’s latest and most detailed outline.

“The long-term vision for a successful TPLC Advisory Program (TAP) is to help spur more rapid development as well as more rapid and widespread patient access to safe, effective, high-quality medical devices of public health importance,” the FDA said in the letter. “A mature TAP will also help ensure the sustained success of the breakthrough dev…

FDA amends EUA for SARS-CoV-2 antibody sotrovimab

GlaxoSmithKline plc (LSE/NYSE:GSK) and Vir Biotechnology (Nasdaq:VIR) have announced that FDA has concluded that the investigational monoclonal antibody sotrovimab is unlikely to be effective against the omicron BA.2 subvariant, which will soon dominate the U.S.

FDA has amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab and its website to exclude the antibody in certain areas.

GSK and Vir were initially optimistic about the antibody’s ability to target the mutations in the spike protein of the original omicron SARS-CoV-2 variant.

Vir shares dropped 13.56% to $21.81. GSK shares were mostly flat, falling 0.046% to $43.28.

The market for SARS-CoV-2 antibodies has been competitive, but emerging variants have limited use of the therapies.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently recommended marketing authorization for AstraZeneca’s (LON:AZN) Evushe…

Cutera’s AviClear acne device wins FDA clearance

[Image from Cutera]Cutera (Nasdaq:CUTR) announced today that it received FDA 510(k) clearance for its AviClear acne treatment device.

Brisbane, California-based Cutera designed AviClear as a laser treatment for the safe, prescription-free reduction of existing acne, while it also demonstrates that, following use, future breakout episodes are shorter, less intense and more infrequent.

The company said in a news release that AviClear represents the only energy-based device to receive FDA 510(k) clearance for the treatment of mild, moderate and severe acne. The platform selectively targets the sebocytes and suppresses sebum production to treat acne outbreaks.

Cutera said that clinical trials showed that acne clearance results with the use of AviClear continue to improve over time, with no pain mitigation utilized or required by any clinical study participant. The company will make AviClear available to physicians throughout the U.S. over the course of 2022. Read more

Sterifre Medical prepares to launch its Aura desktop disinfection device

The Sterifre Aura disinfection system [Photo courtesy of Sterifre]Sterifre Medical is demonstrating its Aura device and courting investors as it prepares to launch the automatic point-of-care disinfection system.

The Aura is a portable machine that circulates hydrogen peroxide and activated oxygen with the push of a single button to disinfect stethoscopes, sensors, pumps, tablets, phones, keys, badges and anything else you can fit in the chamber. The device emits no harmful chemicals, leaves no residue and can get into the nooks and crannies that are hard to reach with the disinfectant wipes and handheld sprays traditionally used in health care settings.

“About 85% of things that are cleaned and disinfected in the hospital go through disinfection, not sterilization,” Sterifre CEO Rick Shea said in an interview. “We thought if we could take this technology, miniaturize it and get it close to point of care, we would clearly have a unique opportunity for a long time …

Sterifre Medical prepares to launch its Aura desktop disinfection device

The Sterifre Aura disinfection system [Photo courtesy of Sterifre]

Sterifre Medical is demonstrating its Aura device and courting investors as it prepares to launch the automatic point-of-care disinfection system.

The Aura is a portable machine that circulates hydrogen peroxide and activated oxygen with the push of a single button to disinfect stethoscopes, sensors, pumps, tablets, phones, keys, badges and anything else you can fit in the chamber. The device emits no harmful chemicals, leaves no residue and can get into the nooks and crannies that are hard to reach with the disinfectant wipes and handheld sprays traditionally used in health care settings.

“About 85% of things that are cleaned and disinfected in the hospital go through disinfection, not sterilization,” Sterifre CEO Rick Shea said in an interview. “We thought if we could take this technology, miniaturize it and get it close to point of car…

Lazurite wins FDA clearance for its wireless camera system for minimally invasive surgery

[Image from Lazurite]Lazurite (formerly Indago) announced today that the FDA cleared its ArthroFree wireless camera system for minimally invasive surgery.

Cleveland-based Lazurite designed the ArthroFree system to incorporate its proprietary low-heat, high-intensity Meridiem light engine technology with advanced camera, battery and wireless transmission technologies and drop-in compatibility with patient data consoles, surgical displays and endoscopes. The company aims for the ArthroFree system to improve operating room productivity, patient safety and economic value.

According to a news release, ArthroFree represents the first and only wireless camera system for minimally invasive surgery to garner FDA clearance. Lazurite announced in January that it was submitting the system for 510(k) clearance.

Lazurite CEO and Co-Founder Eugene Malinskiy called the regulatory nod “the beginning of the operating room of the future.”

“The idea for what…

FDA releases MDUFA V details after industry negotiations

The FDA today released details of its agreement with the medtech industry for reauthorization of the Medical Device User Fee Amendments (MDUFA).

If passed by Congress and signed into law, it would be the fifth version of the Medical Device User Fee and Modernization Act of 2002. AdvaMed lauded the framework earlier this month after regulators and industry representatives negotiated updates to the program, which collects fees from applicants to fund FDA review.

The FDA’s Center for Devices and Radiological Health and Center for Biologics Evaluation and Research will work with companies submitting products for faster, more efficient reviews and decisions without sacrificing product safety or effectiveness, the FDA said in the 38-page MUFDA V commitment letter. For example, the agreement sets the goal of making 510(k) clearance decisions within 128 calendar days for applications received in fiscal year 2023 and reducing that time to 112 days within two years.

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