Approvals

FDA Authorizes Use Of Pediatric Device to Treat Esophageal Birth Defects

The FDA authorized the use of Cook Medical’s Flourish device to treat infants up to one year old for esophageal atresia, a birth defect that causes a gap in the esophagus. The device uses magnets to pull the upper and lower esophagus together.

The agency granted the authorization under the Humanitarian Device Exemption.

FDA Clears Boston Scientific’s Resonate ICD and CRT-D Systems

Boston Scientific has received FDA marketing clearance for the Resonate implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems. The clearance includes SmartCRT technology with multi-electrode pacing and compatibility with the HeartLogic heart failure diagnostic service to help physicians improve heart failure management.

The Resonate ICD and CRT-D devices received a CE Mark in February 2017.

Biotronik Wins FDA Clearance of MultiPole Pacing Device

Biotronik has received FDA marketing clearance of its MultiPole Pacing (MPP) technology, for treatment of heart failure patients who have been non-responsive to cardiac resynchronization therapy. The devices are equipped with a dedicated MRI sensor that shifts to MRI mode and automatically returns to its permanent program when a scan is complete.

The MPP technology is not currently available in the U.S.

Insightec Gains FDA Approval for Exablate Neuro for 1.5T MR

The company has gained FDA approval for its Exablate Neuro system for use with 1.5T MRI in the non-invasive treatment of essential tremor (ET) in patients who have not responded to medication. The MRI-guided device uses focused ultrasound to target and ablate the thalamus with no surgical incisions or implants.

Quidel Corp Wins FDA Clearance for Solana Molecular Assay

Quidel Corp has received FDA marketing clearance from the FDA for its Solana C. difficile assay for the direct, qualitative detection of the Clostridium difficile DNA in unformed stool specimens. The unit can process up to 12 assays in 35 minutes.

STAAR Surgical Achieves CE Mark for the EVO+ Visian ICL with Aspheric Optic

California-based STAAR Surgical has received a CE mark for its EVO+ Visian ICL with Aspheric Optic. The lens is indicated for the correction or reduction of hyperopia and myopia.

EMA Approves Aptar Pharma’s Electronic Lockout Device

Aptar Pharma has received EMA marketing approval for its Instanyl DoseGuard, an electronic nasal lockout device jointly developed with Takeda Pharmaceuticals International.

The lock-out mechanism prevents the device from being used for a period of time after a pre-defined number of spray actuations, to prevent overdose of the opioid.