Spectrawave Inc. has scooped up $13.2 million in a series A-2 financing led by prior investor Deerfield Management. The funds will be used to complete development and regulatory filing for its flagship cardiac imaging technology. Prior unnamed seed investors also participated in the round. With this latest infusion, Spectrawave has raised a total of approximately $30 million to date.

A definitive diagnosis of Alzheimer’s disease often isn’t arrived at until after a patient dies, when their brain is examined during autopsy. Neurovision Imaging Inc. is hoping to change that with reliable, affordable biomarker tests that can detect Alzheimer’s and other forms of dementia and neurodegenerative disorders before symptoms appear.

Medtronic plc said Monday that it has expanded its limited site release of its new radial artery access portfolio. Acquired from Rist Neurovascular Inc. last year, the portfolio includes the Rist 079 Radial Access guide catheter and Rist Radial Access selective catheter. Dublin-based Medtronic completed its acquisition of privately held Rist Neurovascular in August 2020 for an undisclosed sum – the eighth in a series of tuck-in deals the med-tech behemoth has undertaken since January 2020.

Boston Scientific Corp. has received the U.S. FDA’s nod for its Synergy Megatron drug-eluting stent (DES) system. The company said the premarket approval makes Synergy Megatron the first platform in the U.S. that is designed for large, proximal vessels. The Synergy Megatron biopolymer (BP) stent is indicated “for improving coronary artery luminal diameter in patients with symptomatic ischemic heart disease, stable or unstable angina, non-ST elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in native coronary arteries.

Hologic Inc. kicked off its fiscal year 2021 with gusto, reporting revenue of $1.61 billion – up 89.3% year over year, or 86.5% on a constant currency basis. Worldwide sales of molecular diagnostics exceeded expectations, jumping 457.6% to $995.3 million as the company ramped up production to meet growing demand for its two SARS-CoV-2 assays that run on the fully automated Panther and Panther Fusion systems.

Abbott Laboratories reported 2020 fourth-quarter revenue up 29% year over year to $10.7 billion, outpacing the consensus estimate of $764 million. The positive growth was largely fueled by sales in diagnostics, which surged 111% to $4.35 billion, from $2.10 billion in the prior year period. Net earnings for the period totaled $2.16 billion, or $1.20 per share, up from $1.5 billion, or $.59 per share a year ago. Adjusted earnings per share (EPS) was $1.45, ahead of the Street target of $1.35.

Longeviti Neuro Solutions LLC has received the U.S. FDA’s nod for use of its Clearfit cranial implant with postoperative ultrasound imaging. The expanded 510(k) clearance could help in reducing radiation exposure linked to other post-neurosurgical imaging modalities. Research has shown that current methods of post-neurosurgical imaging put patients at risk of radiation exposure, and that an estimated 29,000 future cancers could be linked to CT scan used in the U.S. each year. Comprised of polymethyl-methacrylate (PMMA), Clearfit is a neuro-reconstructive implant that surgeons use to reconstruct a patient’s cranium following brain surgery.

Theranica Bioelectronics Ltd. has snagged an expanded clearance from the U.S. FDA for use of its smartphone-controlled Nerivio device to treat migraines in adolescents. The new indication, for acute treatment of episodic or chronic migraine in people 12 years and older, is supported by a study published last month in the journal Headache.

Boston Scientific Corp. has received a thumbs up from the U.S. FDA for its fourth-generation Vercise Genus deep brain stimulation (DBS) system. The neuromodulation device, which comes in both rechargeable and nonrechargeable versions, is intended to treat the symptoms of Parkinson’s disease. Vercise Genus is indicated for use in the bilateral stimulation of subthalamic nucleus as an adjunctive therapy in alleviating some of the symptoms of moderate to advanced lepodova-responsive Parkinson’s disease that are not adequately controlled by medication. It also has indications for bilateral stimulation of the globus pallidus.