FDA Archives - Page 14 of 103 - Medical Design Sourcing

Outset Medical receives FDA warning letter

Outset Medical (Nasdaq: OM) + announced that it received a warning letter from the FDA listing observations related to its Tablo system.

San Jose, California-based Outset previously disclosed an FDA form-483 on its annual report in February. That FDA form identified four inspectional observations resulting from an inspection concluded on Feb. 10, 2023. From there, Outset provided a response plan on March 3 and completed remediation workstreams to address the observations.

A new warning, dated July 5, raises two additional observations. Outset issued a press release outlining the new warning on July 7. As the markets opened today (July 10), shares of OM fell 14% at $17.60 apiece.

First, the FDA asserts that certain materials it reviewed (found on Outset’s website) promote continuous renal replacement therapy (CRRT). That modality falls outside the current indications for the Tablo hemodialysis system. Outse…

FDA approves next-gen family of pacemakers from Biotronik

The Amvia and CRT-P pacemaker family. [Image from Biotronik]Biotronik announced today that the FDA approved its portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P).

Lake Oswego, Oregon-based Biotronik designed Amvia Edge as the market’s smallest single-chamber MR conditional pacemaker. It offers a set of patient-centric solutions coupled with automated workflow efficiency.

The pacemakers feature Biotronik’s proprietary MRI Guard 24/7 technology. It uses always-on, dedicated sensors to automatically recognize a patient’s entrance into an MRI field. The MRI Guard then converts the device to MRI mode and returns to its permanent programming after the scan completes. This eliminates any pre- or post-scan programming needs.

“MRI Guard 24/7 is a solution for real-world challenges, as we strive to improve safety and increase efficiencies for CIED patients who need MRI access,” said Dr. David Haye…

Abbott wins FDA nod for first dual-chamber leadless pacemaker

The Aveir dual-chamber leadless pacemaker. [Image courtesy of Abbott]Abbott (NYSE: ABT) + announced today that it received FDA approval for its Aveir dual-chamber leadless pacemaker system.

The approval marks the first such nod for a dual-chamber leadless pacing system for treating abnormal or slow heart rhythms. According to Abbott, more than 80% of people who need a pacemaker require pacing in two chambers of the heart — the right atrium and right ventricle.

This approval “significantly increases access” to the pacing technology for millions in the U.S., the company said in a news release.

Approval follows clinical data shared in May that supported Aveir DR. The data came from the company’s large-scale FDA investigational device exemption (IDE) study. Results included a 98.3% implant success rate and more than 97% of patients presenting successful atrio-ventricular synchrony. Abbott said the data sugg…

FDA approves surgical robot device from USMI for open, laparoscopic procedures

US Medical Innovations (USMI) received FDA approval for its Canady Flex RoboWrist for use in open and laparoscopic procedures.

The surgical robot system already has approval in the Middle East, Europe and Asia.

Takoma Park, Maryland-based USMI designed the Flex RoboWrist as a fully articulating, 5 mm handheld surgical instrument. It features a variety of end effectors, including a hook, scissors, needle driver and dissector. The system offers three degrees of freedom and 360 degrees of rotation.

USMI said it includes a connector for its XL-1000 electrosurgical generator, too. This allows the option of using the mono scissors or hook for electrosurgery. The company said it designed the device primarily for dissection, transection and/or suturing of tissue during open, endoscopic and minimally invasive surgical procedures. These include laparoscopic, urologic, gynecologic, general and thoracic surgeries.

Key features include precision and accuracy, …

Invo wins FDA clearance for expanded InvoCell labeling

Invo Bioscience (Nasdaq:INVO) announced that the FDA granted 510(k) clearance to expand the labeling on its InvoCell device.

Sarasota, Florida-based Invo’s InvoCell indication now includes a five-day incubation period. Data supporting this clearance demonstrated improved patient outcomes for the device, which previously had a three-day incubation period.

The company designed InvoCell to allow fertilization and early embryo development to take place in vivo within the woman’s body. InvoCell won FDA de novo approval in November 2015 and launched in the U.S. in April 2016.

“This is a momentous day for Invo as the FDA has provided clearance for us to expand our labeling to cover a 5-day incubation period for InvoCell,” said Steve Shum, CEO of Invo. “This has been a multi-year effort to demonstrate InvoCell’s ability to improve patient outcomes using a longer incubation period, similar to conventional IVF results. We believ…

Cook Medical gets FDA nod for endovascular graft trial for treating aortic aneurysm

The Zenith Fenestrated AAA Endovascular Graft. [Image from the Cook Medical website]Cook Medical received FDA approval to initiate an investigational device exemption (IDE) study for an aortic aneurysm treatment.

The study will evaluate the Zenith Fenestrated + Endovascular Graft (ZFEN+). It assesses the safety and effectiveness of ZFEN+ in combination with Bentley’s InnoMed BeGraft balloon-expandable Fevar bridging stent graft system. The companies aim to look at the treatment of aortic aneurysms involving one or more of the major visceral arteries.

ZFEN+ remains predicated on the commercially available Zenith Fenestrated AAA Endovascular Graft. However, it extends the proximal margin of aneurysmal disease for endovascular treatment. This includes patients with more complex aortic disease. Currently, only open surgical repair stands as an option for treating complex aortic disease, Cook Medical said.

“Outside the United States, Bentley has supplied 3…

CMS proposes new TCET pathway for Medicare coverage of breakthrough devices

The Centers for Medicare & Medicaid Services (CMS) is proposing the new Transitional Coverage for Emerging Technologies (TCET) pathway for breakthrough devices to secure Medicare coverage.

The voluntary program would expedite Medicare coverage for new medtech innovations, offering an estimated three to five years of transitional coverage. CMS repealed a similar program, Medicare Coverage of Innovative Technology (MCIT), in 2021, citing concerns that it may have covered devices without adequate evidence.

The new TCET proposal “supports both improved patient care and innovation by providing a clear, transparent, and consistent coverage process while maintaining robust safeguards for the Medicare population,” CMS said in a statement.

CMS will be taking public comment on the notice for 60 days after publication. The notice is scheduled for publication on June 27, 2023.

CMS is currently seeking public comment on new guidance on evidence…

FDA clears enhancements to plasma collection tech from Haemonetics

Haemonetics (NYSE:HAE) announced that the FDA cleared advancements to its NexSys PCS plasma collection system.

Enhancements include a new plasma collection bowl and new Express Plus technology, according to a news release. The bowl features a patented design to optimize performance and Express Plus reduces procedure time.

Boston-based Haemonetics designed NexSys PCS as a completely integrated system for streamlining plasma collection. It improves yield, productivity, safety, quality, compliance and donor satisfaction. The latest advancements should produce an average procedure time of between 33 and 38 minutes, the company said. It should help customers achieve new levels of plasma center efficiency and lower costs to collect.

Haemonetics says NexSys PCS with NexLynk DMS donor management software already delivers a 16-minute reduction in donor door-to-door time. With Persona technology, it delivers between 9% and 12% additional plasma yield by personaliz…

FDA approves Metavention’s renal denervation for hypertension pivotal IDE study

The iRF renal denervation system. [Image from the Metavention website]Metavention announced today that the FDA granted approval to initiate an investigational device exemption (IDE) trial for its renal denervation system.

Minneapolis-based Metavention designed its integrated radiofrequency (iRF) renal denervation system to treat hypertension. The company plans for its randomized, double-blinded, sham-controlled RADAR study to enroll up to 300 patients across 50 centers. This pivotal study evaluates the safety and efficacy of the iRF renal denervation system.

Metavention designed its iRF denervation system to provide an important distinction to renal denervation procedures: it requires only a single ablation cycle per kidney. The company believes this approach could simplify procedures and reduce the overall burden on patients undergoing renal denervation.

The catheter-based, minimally invasive procedure uses an integrated, multi-RF electrode balloon. It als…

FDA clears Pounce LP thrombectomy system from Surmodics

Surmodics (Nasdaq: SRDX) today announced that it received FDA 510(k) clearance for its Pounce low-profile (LP) thrombectomy system.

News of the regulatory nod comes just one day after Needham analysts upgraded Surmodics stock from “Hold” to “Buy.” The analysts cited positive developments pointing toward the likely approval of Surmodics’ SurVeil platform sooner than previously thought. As of March, the company expected FDA premarket approval for the SurVeil drug-coated balloon in the fourth quarter of 2023.

Mike Matson of Needham said analysts upgraded Surmodics’ stock because of the expectation for SurVeil as “a meaningful growth driver.” They predict the drug-coated balloon should bridge the gap until Sublime and the newly approved Pounce contribute to growth.

Shares of SRDX fell 1.4% at $25.95 apiece in midday trading today.

Get the full story at our sister site, Medical…

FDA removes products from medical device shortage list, reports AED discontinuation

The FDA removed several products from its medical device shortages list and expects the shortage of prefilled saline flush syringes to end soon.

The agency also said Stryker is discontinuing certain automatic external defibrillators (AEDs), a product category for which manufacturers have faced heightened regulatory scrutiny in recent years.

Previously: FDA’s mandatory medical device shortage reporting ends

Relief in sight for prefilled saline flush syringe shortage

Prefilled 0.9% sodium chloride intravenous lock/flush syringes have been in short supply since at least March 2022 due to increased demand. At the same time, supply chain challenges and manufacturing discontinuances have reduced product availability.

These single-use syringes help to prevent blockage of vascular access systems and remove residual medication from the catheter site.

The FDA estimates the prefilled saline flush syringe shortage will end in October 2023. Until then, …

Smith+Nephew wins FDA clearance for shoulder replacement system

The Aetos shoulder system. [Image courtesy of Smith+Nephew]Smith+Nephew (NYSE: SNN) + announced today that it received FDA 510(k) clearance for its Aetos shoulder system.

London-based Smith+Nephew designed Aetos to restore patients’ range of motion and help minimize arthritic shoulder pain. The system features the Aetos Meta Stem designed for maximizing stability, preserving bone and maintaining patient anatomy.

Aetos adds to the company’s upper extremity portfolio. It complements S+N’s sports medicine shoulder repair and biologics products and services, according to the company.

Smith+Nephew said the FDA clearance covers indications for both anatomic and reverse total shoulder arthroplasty. Company officials believe Aetos offers a compact yet comprehensive portfolio of solutions that enhance the surgical experience. According to the company, it requires fewer steps for conversion and fewer instru…