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Masimo’s current board of directors has called on its investors to vote against Politan Capital’s attempted imposition of its own board members in the 19 September meeting that would effectively oust the company’s current CEO. Credit: JHVEPhoto / Shutterstock

US investment firm Politan Capital has been found in contempt of court amid an ongoing dispute with medical device giant Masimo as the investment firm seeks to reselect the company’s board of directors.

A US court ruling found Politan Capital, which is seeking to appoint its own directors to the company, committed contempt of court when it released a 12 September press release on court proceedings despite being subject to a sealing order.

Masimo’s current board of directors has called on its investors to vote against Politan Capital’s attempted imposition of its own board members in the 19 September meeting that would effectively oust the company’s current CEO Joe Kiani as part of a take-over of the company’s upper management.

The statement follows after the US Court for the Central District of California ruled that Politan Capital and Quentin Koffey are in contempt of court in connection with a September 12, 2024 violation of a court order.

The US Food and Drug Administration (FDA) has granted authorisation for the first over-the-counter (OTC) hearing aid software, designed for use with compatible versions of Apple‘s AirPod Pro headphones.

This development allows individuals 18 years or older with mild to moderate hearing impairment to use their AirPods Pro as a hearing aid, following a simple software update and customisation process.

The software-only mobile medical application, Hearing Aid Feature (HAF), employs a self-fitting strategy to enable users to adjust the settings to their preferences without professional assistance.

The HAF is configured using an iOS device, such as an iPhone or iPad, with the user’s hearing levels obtained from the iOS HealthKit to personalise the HAF.

A clinical study involving 118 participants with perceived mild to moderate hearing loss assessed the HAF.

Conducted across multiple US sites, the study found that users who self-fitted the HAF experienced a similar benefit to those who had professional fittings of the same device. 

Johnson & Johnson (J&J) MedTech’s Shockwave Medical has launched the E⁸ peripheral intravascular (IVL) catheter in the US for patients living with certain types of peripheral artery disease (PAD).

Shockwave’s newest catheter, which is designed to deliver four hundred pulses twice per second and has eight emitters, is indicated for patients with calcified femoropopliteal and below-the-knee PAD, including patients with complex chronic limb-threatening ischemia (CLTI), the most severe form of the disease.

More than eight million people aged 40 years and older have PAD in the US, with two million of these patients living with CLTI, with the latter accounting for a large share of amputations occurring in the US each year.

The launch follows the US Food and Drug Administration (FDA) clearance of the technology in March this year, according to the agency’s 510(k) letter. 

Shockwave was brought under the J&J MedTech umbrella earlier this year in a $13.1bn deal.

Respiratory medical device firm Philips has been hit with yet another Class I recall by the US Food and Drug Administration (FDA) after it was found that the software in some of its ventilators was liable to show inaccurate readings, causing false power loss amid a host of other errors. 

The Class I recall was issued by the FDA on 1 October against the company’s Trilogy Evo, Trilogy EV300, Trilogy Evo O2, Trilogy Evo Universal ventilator devices following reports from users that software versions older than version 1.05.10.00 are prone to a series of failures and inaccuracies.

In reporting the recall, the FDA said that beyond inaccurate readings and a liability to give a false loss in power, users had also reported that their devices were prone to false software alarms reporting obstructions or leakage, user interface issues and corrupted data when transferring to another machine. 

Research has found that artificial intelligence (AI) chest X-rays can detect the early symptoms of lung cancer up to three years before symptoms present themselves.

The study, presented at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer in San Diego, found that AI-powered chest X-ray interpretation can detect pulmonary nodules which could develop into early-stage lung cancers before symptoms present themselves.

The retrospective study demonstrated via interim results, an average diagnostic delay of nearly three years from the first abnormal chest X-ray. The study, conducted at Bangkok’s Phrapokklao Hospital’s Cancer Centre of Excellence, used the Qure.ai algorithm, qXR, to detect the cancerous nodules.