Medical device startup Promaxo Inc. has received 510(k) clearance from the U.S. FDA for its office-based MRI system. The portable system is intended for use by urologists and interventional/urologic radiologists who are performing surgical localization of prostatic lesions under Promaxo MRI guidance. It can be used in the office or outpatient surgical setting without the need for significant facility upgrades.

Boston Scientific Corp. has inked an agreement with an affiliate of Baring Private Equity Asia to acquire the global surgical business of Lumenis Ltd. for $1.07 billion up front. The med-tech giant has had a relationship with Lumenis for more than two decades and currently sells its urology laser portfolio in the U.S. and Japan. The transaction, expected to close in the second half of the year, expands Marlborough, Mass.-based Boston Scientific’s global urology footprint.

The U.S. FDA draft guidance for select updates for premarket evaluation of class II atherectomy devices arrived with a lack of clarity that prompted device makers and clinicians alike to request the FDA address several sources of ambiguity. One of these is whether the agency should distinguish between particulate matter from the device vs. calcium particulates from the treated artery, while another is whether particulate evaluation is required only for devices with a coating.

Butterfly Medical Ltd. could be on the verge of metamorphosis into a major player in the benign prostatic hyperplasia treatment field. The Yokneam, Israel-based company just raised $7 million in a series B financing led by New Rhein Healthcare Investors LLC, of Philadelphia.

Israeli startup Olive Diagnostics Pvt. Ltd. is aiming to disrupt at-home urinalysis testing with a hands-free, noninvasive, artificial intelligence (AI)-based solution that provides remote diagnostics by detecting urine’s molecular composition. K2, as the device is called, attaches easily to the toilet rim to generate secure, personalized diagnostic data that directly links to a mobile app.

Israeli startup Bluewind Medical Ltd. has begun enrolling patients at U.S. sites in a pivotal trial of its Renova Istim implantable tibial neuromodulation system for the treatment of overactive bladder.

Medtronic plc has won U.S. FDA approval of its Interstim Micro rechargeable sacral nerve stimulator and Interstim Surescan MRI leads for the treatment of urinary and bowel dysfunctions. The new products make Medtronic the only company to offer a choice between rechargeable and recharge-free sacral neuromodulation (SNM) systems, allowing patients to align their treatment with personal lifestyle preferences.

PARIS – Uromems SAS, of Grenoble, France, reported the completion of a series B round of $17.5 million to advance development of its implantable mechatronic device for treating stress urinary incontinence.

Olympus Medical Systems Group, of Center Valley, Pa., a division of Olympus Corp., is preparing the U.S. launch of the Itind device for the treatment of benign prostatic hyperplasia (BPH), following FDA de novo authorization earlier this year. The nonsurgical, minimally invasive treatment is made by Medi-Tate Ltd., of Or-Akiva, Israel.

Irvine, Calif.-based Axonics Modulation Technologies Inc., which is marketing implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, reported the submission of a premarket approval (PMA) supplement. Specifically, it is looking to gain full-body magnetic resonance imaging-conditional labeling for 3.0 Tesla (T) MRI scans.