Atrial fibrillation can be difficult to diagnose, but patients with untreated AF are 5 times more likely to have a stroke and three times more likely to develop heart failure. Now, the FDA has approved a pair of implantable cardioverter defibrillators from Medtronic specifically for previously undiagnosed and/or asymptomatic AF patients, as well the monitoring and treatment of recurrent AF.
Medtronic has won the first U.S. approval for a leadless pacemaker from the FDA. The inch-long device is the smallest available and is implanted directly into the heart's right ventricle chamber. Traditional pacemakers require wired leads to connect the device to the heart.
CardioFocus has nabbed an approval from the FDA for its HeartLight Endoscopic Ablation System to treat paroxysmal atrial fibrillation.
Medtronic's Arctic Front Cryoballoon ablation catheter for paroxysmal atrial fibrillation is comparable to Biosense Webster's competing Thermocool, the results of a postmarket, head-to-head comparative trial found.
UPDATED: San Diego's Acutus grabs $75M to get 3-D, real-time surgical cardiac imaging past regulators
Acutus Medical has raised a $75 million Series C round to get its 3-D, real-time cardiac surgical imaging system through regulators in U.S. and Europe. It also expects to develop a suite of products specifically for catheter-based procedures. The San Diego-based startup has already got at least a couple of strategic investors--GE Ventures, who is an existing investor, and a mystery undisclosed strategic investor who joined with this latest financing.
Biopharmas are interested in incorporating wearables that offer continuous patient monitoring into clinical trials of their drug candidates. But it's still early in terms of understanding of how these sorts of data can be used--and what regulators will make of them.
AliveCor has an electrocardiogram wrist band that's worn with the Apple Watch. It's been submitted to the FDA, but a launch is pending a 510(k) clearance by the agency. By simply touching the band, the wearer can capture an EKG that's then analyzed by a machine-learning algorithm to detect atrial fibrillation, a common cause of cardiac arrhythmia and a major cause of stroke.
GlaxoSmithKline has been quietly working on bioelectronic medicines for years--after having established an R&D unit dedicated to it in 2012, which was followed by a $50 million venture fund in 2013, and then a $5 million innovation challenge in 2014. Although it hasn't disclosed much about the fruits of its efforts, it has done a new deal to add to them.
Abbott's just-announced acquisition of ablation catheter player Kalila Medical reflects the growing adoption of interventional electrophysiology and other devices to treat atrial fibrillation and stroke.
After disclosing a major restructuring of its medical device business last week, Johnson & Johnson tried to refocus on the future of that group on its annual earnings call. It emphasized doing more deals to acquire platforms for growth, as well as funneling more resources to high revenue growth device groups.