The FDA’s legal authority to regulate lab-developed tests (LDTs) has come into question on several occasions in a number of venues, and the issue is enjoying new life yet again thanks to more activity on Capitol Hill. While two competing pieces of legislation are back in play, the most critical question may be whether the FDA has any authority left at all after the August 2020 rescission letter from the Department of Health and Human Services.

Perkinelmer Inc. has agreed to acquire in vitro diagnostics company Immunodiagnostic Systems Holdings plc (IDS) for approximately $155 million (£110 million). The deal will enable Perkinelmer to expand its overall diagnostics business, particularly the immunodiagnostics segment. Based in Boldon, U.K., IDS makes chemiluminescence products in endocrinology, autoimmunity and infectious diseases. The company has three operating business units: Automated IVD Business, Manual IVD Business and Licensing and Technology.

While saying "white rabbit, white rabbit" on the first of the month may be a luck-bringing superstition, Whiterabbit.ai aims to take luck out of the equation in identifying early breast malignancies. The Santa Clara, Calif.-based company emerged from stealth mode with FDA clearance for its Wrdensity tool, two other products, and more than $49 million in funding to date.

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.

Juno Diagnostics Inc. raised $25 million in a series A financing led by Perceptive Xontogeny Venture Fund. The company has earmarked the funds to support clinical validation studies of the company’s noninvasive prenatal testing (NIPT) solutions. The proceeds will also go toward product development and commercial launch of its NIPT products.

HONG KONG – Ultrasight Ltd. has closed a $13 million series B funding round, and is a step closer to entering the clinic in the U.S. with its cardiac ultrasound software. With the funds in hand, Rehovot, Israel-based Ultrasight aims to start clinical trials in the U.S. for its artificial intelligence (AI)-guided software for cardiac ultrasound.

More than 150 U.S. patents could be at stake if the World Trade Organization (WTO) were to adopt an intellectual property waiver as originally proposed by India and South Africa.

Egnite Inc. emerged from stealth mode in February 2021 with the goal of combining data analytics and digital health technology to illuminate and solve persistent issues in the diagnosis and treatment of structural heart disease. Three months later, it has added artificial intelligence (AI) to its flagship solution, Cardiocare, to drive better diagnosis of aortic stenosis and help physicians predict patient outcomes.

Caris Life Sciences Inc. raised $830 million in a capital growth round led by Sixth Street Partners, the latest show of private investors’ zeal for backing precision medicine ventures. The infusion, which includes $235 million in equity financing, will be used for continued commercial expansion and to advance its liquid biopsy platform. T.R. Price Associates Inc., Silver Lake, Fidelity Management & Research Co. LLC were significant contributors in the round.