Med-El wins FDA nod for Rondo 2 cochlear implant audio processor

Cochlear implant maker Med-El USA said today it won FDA approval for its Rondo 2 cochlear implant audio processor with an expected launch of the device this fall.

The Durham, N.C.-based ocmpany said the newly cleared Rondo 2 audio processor features wireless charging capabilities that allow the device to fully recharge in four hours after being placed onto a charging pad, and can provide 18 hours of battery life.

The system is designed to be worn off the ear and can connect to cell phones, televisions, Bluetooth neckloops and hearing induction loops, Med-EL said, and can be discreetly hidden under hair.

“Rondo 2 is the easiest to use CI audio processor ever made. And because MED-EL engineers every internal cochlear implant to be future-ready, all of our recipients will be able to enjoy the latest industry-leading audio processing technology,” Med-El NA prez & CEO Raymond Gamble said in a press release.

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Report: FDA exempts surgical facemasks from 510(k) requirements

The FDA finalized a rule this week exempting specific disposable respiratory protective masks from 510(k) requirements, according to a Regulatory Affairs Professionals Society report.

The move was adopted in hopes of reducing regulatory burden on manufacturers of the surgical apparel devices and to eliminate the costs associated with regulatory clearance, according to the report.

With the order, which was proposed last December, N95 filtering face piece respirators and surgical N95 respirators will be exempt from 510(k) review, with certain limitations, RAPS reports.

The exemption will only apply to the two single-use respiratory devices, while all other devices under the surgical apparel classification regulation will continue to be subject to review, according to the report.

Yesterday, the FDA approved the first non-opioid treatment designed to help manage the symptoms of opioid withdrawal in adults.

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With groundbreaking approval, Amgen launches new class of medicine for migraine patients

Amgen (NSDQ:AMGN) won FDA approval this week for its once-monthly Aimovig injection designed to prevent the onset of migraines in adults.

The drug is the first of its kind – a molecule that blocks the receptor for a protein that is linked to migraine pain, the calcitronin gene-related peptide. Other major pharmaceutical companies like Eli Lilly (NYSE:LLY) and Teva Pharmaceuticals (NYSE:TEVA) are working on their own CGRP product, but Amgen’s is the first to hit the market.

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

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FDA clears Additive Ortho’s patient specific 3D printed bone segments

Additive Orthopaedics said yesterday it won FDA 510(k) clearance for its Patient Specific 3D-printed bone segments.

The 3D-printed segments are designed to address internal bone fixation in the ankle and foot, the Little Silver, N.J.-based company said.

“This is a tremendous milestone for orthopaedics and the obvious trend towards patient specific 3D printed implants.  In cases of implant revision, limb salvage, and trauma, often there are no clinically available devices to address the patient’s condition.  This is where 3D printed patient specific implants are making significant clinical impacts,” president Greg Kowalczyk said in a press release.

“Our lattice structures are proving to be the next generation design as opposed to the older, more open, types of structures that rely on biologics for osteosynthesis.  In several patients, our lattice structures have shown close to 90% boney in-growth after 6 months using no biologics. We are excited to now offer these as patient specific solutions,” engineering & ops VP Brian McLaughlin said in a prepared release.

Additive Orthopedics said that it recently closed a Series B round of financing, bringing in $1 million.

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FDA approves first non-opioid treatment for opioid withdrawal symptoms

The FDA today approved the first non-opioid treatment designed to help manage the symptoms of opioid withdrawal in adults.

The drug, Lucemyra, isn’t a treatment for opioid use disorder, the agency noted. Instead, it is meant to be used as part of a broader plan to help adults manage their symptoms when they stop using opioids.

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

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Baxter wins FDA nod for Spectrum IQ infusion system

Baxter (NYSE:BAX) said today that it won FDA clearance for its Spectrum IQ infusion system with Dose IQ safety software.

The company touted its system as the first of its kind to include bi-directional electronic medical records integration.

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

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7 medtech stories we missed this week: May 11, 2018

[Image from unsplash.com]

From ReShape submitting an approval application to Health Canada to Conavi receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. ReShape submits for Health Canada approval of ReShape balloon

ReShape announced in a May 10 press release that it has submitted an application to the Medical Devices Bureau of the Therapeutic Products Directorate in Canada to amend its existing Canadian medical device license to include distribution of the ReShape Balloon and its accessories. The ReShape Balloon is FDA approved and is a non-surgical weight loss procedure that uses advanced balloon technology that takes up room in the stomach to help people with high body mass index.

2. FDA clears BrainsWay’s deep TMS stimulator for depression

BrainsWay has received FDA 510(k) clearance for its new stimulator that is used in its Deep Transcranial Magnetic Stimulation (Deep TMS) system to treat major depressive disorder, according to a May 6 press release. The stimulator enhances the Deep TMS system and features BrainWay’s H-Coil helmet to reach deeper and larger surface areas of the brain than standard TMS treatments.

3. Innovative Health wins FDA nod for Xtra DX ultrasound cath

Innovative Health announced in a May 7 press release that it has received FDA clearance to reprocess its ViewFlex Xtra Diagnostic Ultrasound Catheter. The clearance allows the company to develop a full suite of catheters. ViewFlex catheters are used in EP labs to help visualize cardiac anatomy and physiology. The clearance will add more diagnostic, EP-specific device, ultrasound and mapping catheters the company’s current line of products.

4. QT Medical wins FDA nod for home-use ECG

QT Medical has received FDA 510(k) clearance for its home-use 12-lead ECG device, according to a May 4 press release. The device can be used at home by a patient to perform a hospital-grade ECG scan of their heart that is sent through a cloud-based system to a physician for evaluation. When patients are experiencing symptoms following coronary artery bypass surgery or placement of a coronary stent, they can use the QT ECG to connect with their cardiologists in real time where the doctor can diagnose and prevent costly emergency room visits.

5. FDA clears PeraHealth’s clinical surveillance tech

PeraHealth announced in a May 3 press release that it has received FDA 510(k) clearance for its clinical surveillance technology, PeraTrend. PeraTrend is powered by the Rothman Index, which is a measure of a patient’s condition for healthcare providers. It allows hospitals to leverage data within an existing electronic health record to quantify and visualize patient deterioration, risk and improvement in real time.

6. Exact Imaging wins FDA nod for FusionVu

Exact Imaging has received FDA 510(l) clearance for its FusionVu application, according to a May 3 press release. The FusionVu is part of the ExactVu micro-ultrasound system that allows urologists to perform cognitive fusion through Cognitive Assist or micro-ultrasound/MR fusion on the ExactVu high-resolution platform.

7. Conavi wins FDA nod for Novasight hybrid system

Conavi announced in a May 1 press release that it has received FDA 510(k) clearance for its Novasight Hybrid System. The System allows for simultaneous imaging of coronary arteries with intravascular ultrasound and optical coherence tomography. Both imaging methods are used by interventional cardiologists to image coronary anatomy during angioplasty and stunting procedures.

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Cardinal Health’s Cordis wins date with FDA panel for Incraft AAA stent graft

Cardinal Health (NYSE:CAH) subsidiary Cordis this week won a June date with an FDA panel looking to discuss the premarket approval application for its InCraft AAA stent graft system designed for treating infrarenal abdominal aortic aneurysms.

On June 12, the FDA’s Medical Device Advisory Committee’s Circulatory Systems Devices Panel will meet to discuss possible marketing applications for the InCraft, which is currently under evaluation in the company’s Inspiration study.

The Inspiration study has already met its primary safety and effectiveness endpoints, but reported a higher than anticipated rate of certain adverse events, according to an FDA release.

In meeting, the FDA panel will explore “how these events impact the long-term safety and effectiveness, as well as the benefit/risk profile of the device,” according to the release.

Shares in Cardinal Health have risen 5.1% so far today, at $55.47 as of 12:06 p.m. EDT.

Last month, the US Court of Appeals for the Federal Circuit revived a stent patent infringement suit brought by Medinol against Cordis  and its former parent company Johnson & Johnson (NYSE:JNJ).

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Cook Medical wins FDA de novo nod for Hemospray

Cook Medical said yesterday it won FDA de novo clearance for its Hemospray endoscopic hemostat designed for treating bleeding in the gastrointestinal tract.

The Hemospray product won indications from the FDA for treating non-variceal GI bleeds, the Bloomington, Ind.-based company said. Hemospray is a single-use device designed to deliver an aerosolized spray of a mineral blend to a bleeding site during endoscopic procedures, and can cover large areas including ulcers and tumors, according to an FDA release.

“We are extremely pleased to receive this approval to market from FDA. We have worked diligently to bring a different approach to hemostasis for gastroenterology teams across the United States,” Cook Medical endoscopy VP Barry Slowey said in a prepared release.

“Hemospray gives clinicians another tool for the care of their patients. Patients have been our number one priority for over 50 years and we’ve worked hard to bring this innovation to the field of gastroenterology across the U.S.,” Cook Medical MedSurg VP DJ Sirota said in prepared remarks.

The Hemospray powder is intended to absorb the water in blood to form a gel which acts both cohesively and adhesively to create a barrier to the bleeding site, Cook Medical said.

In its approval, the FDA said it reviewed data from studies of 228 patients with upper and lower GI bleeding alongside real-world evidence from medical literature reports which included data on an additional 522 patients. The Hemospray device was found to have stopped GI bleeding in 95% of patietns within 5 minutes of device usage.

The FDA said that 20% of patients experienced rebleeding between 72 hours and 30 days, and bowel perforations were observed in 1% of patients.

“The device provides an additional, non-surgical option for treating upper and lower GI bleeding in certain patients, and may help reduce the risk of death from a GI bleed for many patients,” FDA Center for Devices and Radiological Health surgical devices division director Dr. Binita Ashar said in a press release.

Early last month, Cook Medical said it re-launched its Beacon Tip Torcon NB advantage catheters in the US and Canada, after having recalled the devices due to complaints related to device tips on the items degrading and fracturing.

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CardioFocus wins FDA nod for HeartLight AF balloon

CardioFocus said today it won FDA approval for its HeartLight Excalibur balloon designed to treat paroxysmal atrial fibrillation.

The Marlborough, Mass.-based company said that the newly cleared balloon uses technology from its HeartLight endoscopic ablation system alongside a new feature set intended to improve speed and magnitude of tissue contact during pulmonary vein isolation procedures.

“We have seen encouraging results with the Excalibur Balloon. It obtains an impressive antral position and establishes even more tissue contact, which enables contiguous lesion sets. This is a clear advance in the field of balloon-based AF ablation, delivering on the promise of an ultra-compliant balloon,” Dr. Vivek Reddy of Mount Sinai’s Icahn School of Medicine said in a press release.

The Excalibur balloon also features CardioFocus’ dynamic response technology which allows for the operator to make real-time adjustments to balloon size to improve optimal tissue contact, which the company claims maximizes engagement of the balloon with pulmonary veins and decreases ablation procedure time.

“The FDA approval of the Excalibur Balloon is a significant milestone for CardioFocus, as it is the first ultra-compliant balloon introduced into the US market for AF ablation. The Excalibur Balloon capitalizes on the existing features of our HeartLight System, which offer an accurate, consistent, and controlled treatment option for PAF patients whose atrial arrhythmias are insufficiently controlled with medication,” COO Burke Barrett said in a prepared statement.

The Excalibur balloon won CE Mark approval in the European Union last September, and the company has since commercially launched the device in the region.

CardioFocus said it expects to being a full commercial launch of the device in the US during the third quarter of this year.

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