Approvals

BioTronik Earns CE Mark for Injectable Cardiac Monitor

BioTronik’s injectable cardiac monitor for tracking arrhythmias, the BioMonitor III, has earned the CE Mark and is now available on the European market.

The device is designed to help patients with irregular heart rhythms by detecting and recording suspected arrhythmia and unexplained loss of consciousness caused by low blood pressure.

The monitor works in conjunction with the devicemaker’s home monitoring system and requires no patient interaction.

Chembio Nabs CE Mark for Multiplex Diagnostic

Chembio Diagnostics has earned the CE Mark for its point-of-care Dual Path Platform (DPP) multiplex test for the Zika, dengue and chikungunya viruses.

The diagnostic provides simultaneous detection of the antibodies for active and prior exposure to the viruses — an important distinction for treatment.

The test uses a small drop of blood from the fingertip and works in conjunction with the company’s DPP Micro Reader device to provide results in approximately 15 minutes.

FDA Clears Benvenue’s Expandable Interbody Device

The FDA has handed Benvenue 510(k) clearance for its Luna XD expandable interbody device for use in patients with symptomatic degenerative disc disease.

The minimally invasive device is inserted via a small incision and gives the patient’s spine anterior column stability, strength and fusion.

The implant includes a large graft chamber to promote successful fusion and restoration of maximum height.

Viveve Earns FDA Clearance for Collagen Builder

The FDA granted Viveve 510(k) clearance for its Viveve 2.0 system, a cryogen-cooled monopolar radiofrequency device used to rebuild natural collagen in female patients.

The device is used in general procedures for electrocoagulation and hemostasis, using controlled cooling to protect tissue from damage while allowing for greater penetration of its radio waves.

The system uses a small probe that emits cryogen-cooling and radio waves to spur the production of new collagen and tissue reinvigoration.

Quidel Earns 510(k) Clearance for Triage TOX Drug Screen

Quidel Corporation received 510(k) clearance from the FDA for its Triage TOX Drug Screen, 94600, a fluorescence immunoassay for detecting the presence of drug and/or metabolites in human urine of up to nine drug assays.

Results are typically displayed in approximately 15 minutes from the addition of specimen and are stored in the meter’s memory to display or print when needed. If connected, the Meter can transmit results to the laboratory or hospital information system.

The test is used with Quidel’s Triage MeterPro instrumented system. The company is optimistic that the assay will boost its Triage sales and create further growth for its MeterPro instruments. “We believe that our latest diagnostic screening test can play an important role in providing fast, diagnostic answers to healthcare providers in the emergency and urgent care settings,” said Quidel’s CEO, Douglas Bryant.

RYAH Medtech Gains CE Mark for Dry Herb Vaporizer

RYAH Medtech has received the CE Mark from the British Standards Institute for its RYAH vaporizer, a device used to administer dry herb medicine.

The vaporizer, which enables patients to precisely control the device’s temperature and the dosage they inhale, is expected to launch in Europe in the near future.

The device can stay clean by using RYAH cartridges that prevent material from coming into direct contact with the heating chamber.

Avioq’s HIV Assay for Reactive Samples Gains CE Mark

Avioq’s VioOne HIV Profile Supplemental Assay has earned the CE Mark and is seeking distribution partners for Europe.

The enzyme-linked immunosorbent assay (ELISA) confirms and distinguishes between individual antibodies directed to various gene products of HIV-1 and HIV-2 in human serum and blood plasma.

The test is specifically used to confirm the presence of HIV-1 or HIV-2 antibodies in specimens that were repeatedly reactive during diagnostic screening procedures.