Approvals

FDA Approves First EpiPen Generics

The FDA approved the first generic versions of Mylan’s EpiPen and EpiPen Jr., giving Teva permission to market its generic epinephrine auto-injector in 0.3mg and 0.15mg strengths.

FDA Commissioner Scott Gottlieb said the approval is part of FDA’s “longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval.”

Teva did not immediately disclose the prices of the new products.

Avita Gets Expanded Compassionate Use for Burn Treatment Device

The FDA approved a large increase in the number of patients who may use Avita’s Recell autologous cell harvesting device, used for severe burns, under a compassionate use investigational device exemption (IDE) program.

With the approval, up to 108 patients suffering from severe and life-threatening burns may be treated with the Recell device and up to 26 U.S. burn centers may participate.

The compassionate use IDE program allows patients to be treated with the device before it receives FDA approval.

Caretaker Medical Receives CE Mark for Vital Signs Monitor

Caretaker Medical successfully received a CE Mark for its wearable, wireless vital signs monitor.

The continuous non-invasive “beat by beat” blood pressure and wireless vital signs monitor was already approved by the FDA.

The device measures blood pressure, heart rate, SP02 and body temperature and does not use external arm cuffs or arterial catheters.

FDA Rejects Endobronchial Coil System for Treating Severe Emphysema

Elevair’s premarket approval (PMA) application for its endobronchial coil device was shot down by the FDA.

The coil system is meant to reduce lung volume and hyperinflation by applying compression to damaged tissue and helping the lungs regain elastic recoil.

The device is designed to treat severe emphysema using a minimally invasive, bronchoscopic technique to place memory coils in the patient’s lungs.

NetScientific Receives CE Mark for Immunoassay

NetScientific earned a CE Mark for its ProteaseTag active Pproteinase-3 immunoassay and announced its firm commercial sale to a US biotech company.

The immunoassay is designed for clinical researchers investigating chronic respiratory conditions, such as cystic fibrosis, bronchiectasis and chronic obstructive pulmonary disease, in both commercial and academic areas.

7D Surgical’s Cranial Module Device Receives FDA Approval

The FDA granted 510(k) clearance for 7D Surgical’s machine-vision image guided surgery (MvIGS) system for use in cranial surgery.

The device uses machine vision algorithms and camera-based tech to acquire virtual fiducial markers from the patient’s anatomy, allowing for cranial registration in nearly any surgical position.

It can also register multiple datasets to visualize the patient’s anatomy using many types of medical imaging.

FDA Grants 510(k) Clearance to BioSig’s Cardiac Signal Device

BioSig Technology’s Pure EP System, a medical device that measures, records and displays high fidelity cardiac signals, received 510(k) clearance from the FDA.

The device is intended for use in an electrophysiology (EP) laboratory to provide visualization tools that can help to analyze a patient’s intracardiac and electrocardiographic signals during EP procedures.

The computerized system is non-invasive and can potentially increase the diagnostic value of the signals, improving EP study accuracy and efficiency. It is indicated for use by licensed healthcare practitioners who interpret the data.

Procleix’s Zika Assay Earns FDA Approval for Use With Panther System

The FDA approved Procleix’s Zika virus assay for blood screening on Procleix’s Panther system.

The assay is approved for detecting the Zika virus in donated individual or pooled plasma specimens, making it useful for blood banks in their efforts to screen blood donations for the virus.

It is also approved to test plasma or serum samples to screen other living or dead organ donors and human cells, tissues and cellular and tissue-based products.

Inova Diagnostics’ Assay Cleared by FDA

The FDA granted clearance to Inova Diagnostics’ Quanta Flash HMGCR, a marker that helps to diagnose idiopathic inflammatory myopathy, a group of disorders that involve the inflammation of muscles used for movement.

The assay is one of thirty others cleared by the FDA for use on the Bio-Flash device, a random access chemiluminescent analyzer used in autoimmune laboratories.

Inova’s test can help distinguish between patients with self-limited myopathy who will likely recover and patients who are at severe risk of illness and often need aggressive immunosuppressive therapy.