FDA Archives - Page 12 of 103 - Medical Design Sourcing

FDA clears Abbott Alinity h-series hematology system

The Alinity h-series hematology system. [Image courtesy of Abbott]Abbott (NYSE: ABT) + announced today that the FDA cleared its advanced Alinity h-series hematology system.

FDA clearance enables laboratories to run complete blood counts (CBCs) as part of Abbott’s Alinity family of diagnostic products. CBCs, among the most ordered tests in healthcare, help to screen for a variety of disorders. That includes infections, anemia, diseases of the immune system and blood cancers.

The Alinity h-series includes Alinity hq, an automated hematology analyzer, and Alinity hs, an integrated slide maker and stainer. Abbott said Alinity hq’s key differentiator is the leveraging of advanced MAPSS technology. MAPSS uses light scattering to distinguish cellular features and better identify various blood cells.

Abbott says that bringing the Alinity h-series to market enables it to offer one of the broadest laboratory diag…

Movano submits smart ring for pulse oximetry to FDA

The Evie smart ring. [Image courtesy of Movano Health]Movano Health (Nasdaq:MOVE) announced today that it submitted a 510(k) premarket notification to the FDA for its Evie Ring.

The submission passed the first milestone of the review process — an initial review for completeness. It’s now under full FDA review for pulse oximetry measurements.

Pleasanton, California-based Movano unveiled the Evie smart ring designed specifically for women in December 2022. Evie offers intelligence and comfortability in a sleek appearance. It provides users with medical-grade health data for translation into personalized insights delivered through a mobile app.

Evie offers measurements for resting heart rate, heart rate variability, SpO2, respiration rate, skin temperature variability, period and ovulation tracking, menstrual symptom tracking, activity profile, including steps, active minutes and calories burned, sleep stages and duration, and mood tracking. It delivers …

Imperative Care reports positive data for stroke treatment following expanded FDA nod

[Image from Imperative Care]Imperative Care today announced positive data from a neurovascular outcome database evaluating its Zoom stroke solution.

The announcement for the study results comes just a week after the FDA cleared an expansion to the Zoom portfolio. Imperative Care will discuss its Zoom platform and its efforts to build next-generation devices at DeviceTalks West in October. Check out the agenda and register HERE.

Campbell, California-based Imperative Care develops connected technology to treat stroke and other ischemic diseases. The Zoom stroke solution product platform aims to usher in a new era of stroke thrombectomy. It enables fast and consistent treatment, plus improved procedure outcomes. Through reperfusion, physicians can perform fast, effective clot removal in patients with ischemic stroke.

The company presented data from its Neurovascular Quality Initiative-Quality Outcome Database (NVQI-QOD) at the Society of NeuroInterventional Su…

FDA grants breakthrough nod for water vapor ablation therapy from Francis Medical

Francis Medical’s cancer ablation device delivers water vapor that cools and kills cancer cells. [Image courtesy of Francis Medical]Francis Medical announced that the FDA granted breakthrough device designation for its Vanquish water vapor ablation therapy.

The Minneapolis-based company designed its proprietary, minimally invasive Vanquish therapy to treat prostate, kidney and bladder cancer.

Vanquish water vapor technology applies the thermal energy stored in drops of water to deliver targeted treatments to cancerous tissue. It takes place through a simple transurethral procedure. Francis Medical designed Vanquish to ablate cancer cells while protecting the surrounding structures. This lessens the likelihood of life-altering side effects that can come with other prostate cancer treatments.

Francis Medical remains in the process of initiating its VAPOR 2 pivotal study in support of submission for FDA clearance. The trial aims to treat 235 patients wit…

FDA clears BD combo test for COVID-19, flu, RSV

The BD Max system. [Image courtesy of BD]BD (NYSE: BDX) + announced today that the FDA granted 510(k) clearance for its respiratory viral panel (RVP).

Franklin Lakes, New Jersey-based BD designed the RVP for its BD Max system as a single molecular diagnostic that identifies a number of viruses. It distinguishes SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) in approximately two hours.

The FDA granted the test emergency use authorization (EUA) in February. It uses a single nasal swab or single nasopharyngeal swab sample to determine if a patient has COVID-19, the flu or RSV. BD says its RVP test helps to eliminate the need for multiple individual tests or doctor visits. It can also help clinicians implement the right treatment plan in a fast and efficient manner.

Co-testing also helps to increase testing capacity during the busy flu season and speed up diagnosis time, BD added.

…

Teleflex wins expanded FDA indication for QuikClot Control+ hemostatic device

Teleflex (NYSE: TFX) + announced today that the FDA expanded the indication for its QuikClot Control+ device.

The expanded indication for the hemostatic device includes mild and moderate bleeding in cardiac surgical procedures. It also includes bone surface bleeding following a sternotomy. Indication expansion allows clinicians to use QuikClot Control+ to control all bleeding in cardiac surgical procedures. Teleflex says this enables device utilization across a wider patient population and breadth of surgical procedures.

Wayne, Pennsylvania-based Teleflex bought QuikClot Control+ as part of its $500 million acquisition of Z-Medica in 2020. The device also received expanded uses to include patients on anticoagulation/antiplatelet medication. It can treat patients with or without autotransfusion (blood salvage) equipment and be used with or without cardiopulmonary bypass sys…

FDA approves another over-the-counter Naloxone nasal spray

The RiVive over-the-counter naloxone nasal spray. [Image from Harm Reduction Therapeutics]

Harm Reduction Therapeutics announced that it received FDA approval for its over-the-counter RiVive naloxone nasal spray.

Pittsburgh-based HRT designed the 3 mg naloxone HCl nasal spray for the emergency treatment of opioid overdose. Approval helps make free or low-cost OTC nasal spray widely available in the U.S.

The FDA first approved Narcan 4 mg OTC naloxone nasal spray in March of this year. A different opioid overdose therapeutic, the Opvee nalmefene hydrochloride nasal spray from Opiant Pharmaceuticals, received approval in May.

RiVive uses an easy-to-use standard dose unit system. Each nasal spray device contains one dose. HRT plans to offer it exclusively in twin packs containing two single-dose devices.

“We are grateful that FDA granted RiVive approval so we can now achieve what most thought i…

Baxter warns on some infusion pumps due to potential false alarms

The Spectrum IQ infusion system. [Image from Baxter]Baxter (NYSE:BAX) issued an urgent medical device correction for some Spectrum V8 and Spectrum IV infusion pumps in the U.S.

Affected pumps in the U.S. and Puerto Rico received upgrades to software versions v8.01.01 and v9.02.01. Baxter issued the correction due to an increase in reported false upstream occlusion alarms following the software upgrades. The Deerfield, Illinois-based company plans to revert the software to the previous version on all affected pumps.

Baxter’s notice said that the upgraded software may cause an alarm for upstream occlusion when one isn’t present. That can lead to an interruption or delay of therapy, potentially causing serious adverse health consequences for users.

Get the full story at our sister site, Drug Delivery Business News.

FDA issues draft guidance on opioid-use disorder devices

The FDA today released draft guidance for developers of devices meant to treat opioid-use disorder.

The agency cited the specific challenges of designing clinical studies to evaluate these devices, including inaccurate self-reporting of drug use, missing data, the confounding effects of related drug treatments and the lengthy observation periods needed to demonstrate therapeutic.durability.

For example, the FDA said pivotal device studies to support marketing submissions “should have a well-defined study population, appropriately monitor drug use, control for bias and include an appropriate follow-up period, study participant retention plans and data analysis plans.”

Related: Could minimally invasive neuromod tackle the opioid epidemic?

The FDA wants feedback on the draft guidance to review before finalization. The agency said the guidance doesn’t apply to diagnostics for opioid use or opioid use disorder, combination products, o…

This tiny saliva sensor could track acidity, glucose, medication and more

A rendering of Lura Health’s saliva sensor with a U.S. penny for scale [Image courtesy of Lura Health]

Lura Health has developed a tiny, wireless oral sensor for saliva monitoring to track acidity and much more in the years ahead.

The company aims to start by noninvasively measuring saliva acidity to help prevent tooth decay, which is the most prevalent health condition globally and the most common chronic disease in children and young adults.

“It affects at some point around 90% of Americans,” Lura Health co-founder and CEO Daniel Weinstein said in an interview with Medical Design & Outsourcing. “There’s a population set for which it imposes a huge burden. And dental expenditures are $162 billion or more in the U.S. alone, so it’s a big economic and health toll.”

Weinstein founded the company in 2017 with Chief Medical Officer Dr. Saam Bozorg and Chie…

The flaw that likely caused Medtronic’s massive ICD and CRT-D recall — and why they’re too risky to replace

Medtronic has recalled implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators that may fail to deliver life-saving shocks for cardiac patients. [Photo courtesy of Medtronic]

Medtronic identified a likely design flaw that can cause defibrillator implants to halt life-saving shocks for cardiac patients.

An insulation defect appears to be to blame for Medtronic’s massive Class I recall of implantable cardioverter defibrillators (ICDs), including cardiac resynchronization therapy defibrillators (CRT-Ds).

The FDA said it has not yet determined a cause and that Medtronic is investigating. But Medtronic — the world’s largest medical device manufacturer — identified the likely problem in an urgent medical device correction notice sent to healthcare providers.

Medtronic identified 348,616 devices in the U.S. for the recall, distributed from Oct. 13, 201…

FDA clears updated BD Alaris infusion system after long-term commercial hold

The Alaris infusion system. [Image courtesy of BD]BD (NYSE: BDX) + announced today that the FDA granted 510(k) clearance for its updated Alaris infusion system.

Shares of BDX closed out Friday evening priced at $264.84 each. They ticked up significantly after market close on the back of the Alaris news, rising 5.9% to $280.40 apiece.

Clearance enables both remediation and a return to full commercial operations for the previously maligned infusion system. It covers updated hardware features for the point-of-care unit (PCU), large-volume pumps, syringe pumps, patient-controlled analgesia (PCA) pumps, respiratory monitoring and auto-identification modules.

The updated clearance also covers a new software version with enhanced cybersecurity, plus interoperability features. These enable smart, connected care with the most widely used electronic medical record (EMR) systems.

“The 510(k) clearance of the upda…