FDA Archives - Page 78 of 103 - Medical Design Sourcing

FDA grants IDE approval for Cerus Endovascular’s Contour Neurovascular System clinical study

Cerus Endovascular announced today that it received FDA investigational device exemption for a trial for its Contour Neurovascular System.

Fremont, Calif.–based Cerus’ Contour Neurovascular System is designed to treat intracranial aneurysms. Its creators made it of fine mesh braid to target the neck of the aneurysm away from the vulnerable dome.

It’s possible to self-anchor the system for stability. It’s re-sheathable for precise placement, and the sizing criteria are less restrictive because of its deployment across the neck. It received FDA breakthrough device designation in February of this year.

According to a news release, the study is designed to produce a data set that will support the safety and efficacy of the Contour Neurovascular System for the endovascular embolization of wide-necked, bifurcated, saccular intracranial aneurysms. Cerus intends to submit results in a premarket approval application to the FDA.

“We …

J&J Vision wins regulatory nods for phacoemulsification machine

Johnson & Johnson Vision (NYSE:JNJ) announced today that it received FDA 510(k) clearance and CE mark for its Veritas vision system.

Santa Ana, Calif.–based Johnson & Johnson Vision’s next-generation Veritas phacoemulsification system is designed to allow surgeons to guide through any lens density with less surge and more stability. It also incorporates advancements in ergonomics to enhance usability during cataract surgery, according to a news release.

Veritas’ approvals in the U.S. and Europe follow recent FDA nods for J&J Vision’s Tecnis Eyhance and Tecnis Eyhance Toric II intraocular lens for treating cataract patients, the company said.

Johnson & Johnson Vision intends to begin the full commercial launch of the Veritas system around the globe later this year, the company said.

“While the phacoemulsification technique has been used successfully for decades, ease of use continues to be the unmet need wi…

LivaNova gains FDA clearance for heart-lung machine

LivaNova (NSDQ:LIVN) announced today that it received FDA 510(k) clearance for its B-Capta system integrated into the S5 heart-lung machine.

London-based LivaNova’s B-Capta, a new, in-line, blood-gas monitoring system is to be integrated into the S5 HLM to easily and accurately monitor arterial and venous blood gas parameters even during long and complex pediatric and adult cardiopulmonary bypass procedures.

B-Capta received CE mark approval in Europe in May 2020 and completed a limited commercial release in Europe. It will now be available globally.

The system uses sensing technology to provide accurate and continuous measurements to allow the perfusionist to quickly react to parameter changes. Its interface reduces set-up time, aligns parameters to those of the hospital’s laboratory blood gas analyzer and includes accurate oxygen partial pressure measurements.

“B-Capta significantly extends the in-line, blood-gas monitoring options a…

FDA just made pooled COVID testing easier

(Image from Mayo Clinic)

COVID-19 molecular tests have already been authorized for individual use will have an easier time getting an FDA nod for pooled testing.

The FDA said today it will add tests by manufacturers who validated their nasal specimen test for pooling to its list of tests available for use with pooled nasal specimens. This could expand the number of tests that schools and employers can use to routinely screen asymptomatic individuals for SARS-CoV-2, the virus that causes COVID-19.

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Medtronic blood pump recall is serious

Medtronic Bio Console 560 system (Image from Medtronic)

Medtronic (NYSE: MDT) is recalling a blood pump that can stop during cardiopulmonary bypass surgery due to electrical failure.

The Bio-Console 560 extracorporeal blood pumping console is used to pump and return blood to a person during bypass, a procedure that temporarily takes over the function of the heart and lungs. The cardiopulmonary bypass procedure provides both circulatory and breathing support to a person whose heart and lungs are too weak to pump enough blood to the rest of the body.

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Canon Medical cardiac CT wins FDA clearance

Canon Medical Systems announced today it received FDA 510(k) clearance for expanded capabilities with its Deep Learning Spectral CT.

Tustin, Calif.-based Canon’s Deep Learning Spectral CT’s expanded capabilities reach into cardiovascular applications now, according to a news release.

The CT is available on Canon’s Aquilion ONE/Prism Edition CT system, offering healthcare providers the ability to acquire whole-heart spectral images in one beat. The system includes a 16 cm-wide area detector, 0.275-second whole-heart acquisition capabilities and rapid kVp switching with deep learning spectral reconstruction.

Aquilion ONE/PRISM Edition integrates AI to offer conventional and spectral CT capabilities along with deep clinical insights to give physicians the means to make more informed decisions across the care continuum.

“By integrating AI into spectral imaging, Canon Medical is bringing innovative technology to the market that can ma…

Another BD Alaris infusion pump recall is Class I

The FDA has identified another recall for the Alaris infusion pump from BD (NYSE:BDX) as Class I, the most serious kind of recall.

BD’s latest recall, initiated on March 3, 2021, involves its BD Alaris infusion pump module system, which includes an infusion pump and vital signs monitoring system with a PC unit, the Guardrails Suite MX and up to four removable infusion or monitoring modules (channels), according to an FDA notice.

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

FDA approves Bristol-Myers Squibb immunotherapy for gastric cancer

The FDA announced today that it approved Opdivo (nivolumab) in combination with chemotherapy to treat gastric cancer, among other diseases.

Opdivo, developed by Bristol-Myers Squibb, when used in combination with certain types of chemotherapy is designed to treat advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. It is now the first FDA-approved immunotherapy for the first-line treatment of gastric cancer, according to a news release.

The monoclonal antibody is designed to enhance T-cell function to inhibit tumor growth. In a randomized, multicenter, open-label trial of 1,581 patients with previously untreated advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, the 789 patients who received Opdivo with chemotherapy lived longer on average than the 792 patients who received chemo alone.

Median survival for patients who received Opdivo plus chemotherapy c…

FDA finalizes rule to scale back how it regulates medtech software

The FDA today issued a ruling that amends medical device classification regulations related to the 21st Century Cures Act.

In an unpublished ruling (it will officially be published on Monday, April 19, 2021), the FDA stated that it took this action to ensure that its regulations conform to the medical software provisions in the Cures Act.

In December 2016, then-President Barack Obama signed the 21st Century Cures Act, which included some provisions intended to improve the regulatory process for medical devices.

Among the provisions was a clarification on the FDA’s role in regulating medical software. Previously, the FDA had regulated image analysis software and IVD technology — and continued to do so after Obama signed the 21st Century Cures Act. However, under the law’s provision, the FDA can not regulate software that uses “big data” to provide clinical decision support to healthcare professionals.

The section has a few exceptions fo…

Medtronic has another serious HVAD recall

Medtronic’s HVAD [Image courtesy of Medtronic]The FDA is reporting 12 deaths related to a recall of Medtronic (NYSE:MDT) HeartWare Ventricular Assist Device controller ports.

The recall — which Medtronic initiated on Feb. 26 and FDA designated as Class I — is related to 855 complaints and eight reports of injuries, according to the FDA. Medtronic said today that the FDA’s figures are inaccurate.

The HVAD pump helps the heart continue to pump blood to the rest of the body, providing a bridge to cardiac transplants among people at risk of death from end-stage left ventricular heart failure. HVADs can also support heart tissue recovery and provide a destination therapy when there are no plans for new transplants.

The latest recall involves battery cables, data cables, adapter cables and controller 2.0 ports for HeartWare, according to FDA. Wear and tear of the connector plugs (power sources, data cable, and alarm adapter) can damage the controller …

FDA clears Acutus Medical suite of universal transseptal crossing devices

Acutus Medical announced that it received FDA clearance for its AcQCross family of universal transseptal crossing devices.

Carlsbad, Calif.-based Acutus touts the AcQCross system as the first and only transseptal puncture system specifically engineered to pair and mate seamlessly with Acutus’ suite of sheaths, as well as with sheaths sold by other manufacturers, according to a news release.

Get the full story at our sister site, Medical Tubing & Extrusion.

HHS shoots down ‘flawed’ plan to let some devices skip review

HHS Secretary Xavier Becerra (Image from Gage Skidmore on Flickr)

The Biden administration has nixed what it described as a “flawed” Trump-era decision to exempt certain medical devices — including infusion pump controllers and fetal monitors — from regulatory review.

HHS published the original notice in the Federal Register on Jan. 15, shortly before President Joe Biden was set to take office, without speaking with the FDA before doing so, according to an FDA notice set to appear in the Federal Register tomorrow.

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