Becton, Dickinson & Co. (BD) is looking to ease the burden on microbiology labs with the U.S. launch of its urine culture analysis imaging application by automating microbiology processes. Powered by artificial intelligence (AI), the app is intended for use on the device manufacturer’s Kiestra lab automation incubation and imaging system.

TORONTO – Ambu Inc. has won Health Canada clearance for a flexible, single-use cystoscope for diagnosing, managing, and treating lower urinary disorders such as incontinence and bladder cancer. The disposable Ascope 4 Cysto system goes head-to-head with reusable urology scopes that must be reprocessed after each use, diminishing image quality and mechanical performance, said Jens Kemp, Ambu’s vice president of marketing for North America.

Renovia Inc. closed a $17 million C-1 equity funding round led by new investor Parian Global Management. Perceptive Life Sciences, Longwood Fund, Ascension Ventures and OSF Ventures added to their existing investments in the company, which develops prescription digital therapeutics for female pelvic floor disorders.

PERTH, Australia – Analytica Ltd. signed a joint venture agreement with Hebei Nacol Bio-Technology Co. Ltd. and Shijiazhuang Biosphere Pty Ltd., of Hebei Province, China, to manufacture and distribute its Pericoach device for urinary incontinence in China, Macau, Hong Kong and Taiwan.

I-O Urology Corp. launched its Carepath platform to provide remote patient monitoring for urologic conditions. The platform uses a compact portable system to capture real-time urine voiding data and a mobile app to facilitate accurate reporting and timely communication between patients and their health care providers.

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.