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Home » Topics » Medical devices and technologies » Software

Software
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Woman using Paige software on tablet

Paige receives FDA de novo authorization for AI product for prostate cancer detection

Sep. 22, 2021
By Annette Boyle
The FDA granted de novo marketing authorization for Paige Prostate, artificial intelligence (AI)-driven software that improves detection of prostate cancer. The clinical study submitted to the FDA demonstrated that using Paige Prostate resulted in a 7% improvement in sensitivity in correctly diagnosing cancer, increasing from 89.5% to 96.8%.
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Australian flag on laptop screen with health professional

TGA provides clarity on software for rapid antigen tests for COVID-19

Sep. 21, 2021
By Mark McCarty
The COVID-19 pandemic is still swirling about, and rapid antigen tests are still playing a vital role in pushing back against the COVID-19 pandemic, and Australia’s TGA has responded with a guidance on when software used with rapid antigen tests qualifies as a regulated device. The TGA has classified such software as a class 3 device when used with a rapid antigen self-test, thus requiring a separate regulatory application before it can be eligible for entry in the Australian Register of Therapeutic Goods (ARTG).
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Ipad displaying Signalpath program

Verily expands Project Baseline with Signalpath acquisition

Aug. 18, 2021
By Annette Boyle
Verily Life Sciences LLC, a division of Alphabet Inc., took its first major step to fulfill its goal of transforming clinical trials with the announcement of an agreement to buy Signalpath LLC for an undisclosed sum. The deal is Verily’s first major acquisition since the company spun out of Google Inc. in 2015. It’s likely not the last deal for the company in the short-term, however, as it raised $700 million in December 2020 to fund its aggressive expansion plans.
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Health, medical icons

Australia issues new regs for software-based medical devices that may change classifications

Aug. 17, 2021
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is warning device manufacturers that new regulations for software-based medical devices may have changed the classification of devices currently on the market, and these devices will need to be re-registered if they are to stay on the market.
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Product recall concept image

Baxter’s Dose IQ software the subject of a class I recall

Aug. 13, 2021
By Mark McCarty
The FDA applied a class I tag to the recall of Dose IQ software used in infusion pumps made by Baxter Healthcare because of a defect in the software, although there have been no reported injuries or fatalities. The defect is blamed for creating mismatches between the drug library and the drug loaded into the infusion pump, which can lead to potentially deadly over- or under-infusion of the medication.
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Desk with computer monitor displaying Genieus' software

Genieus builds neurodegenerative diseases platform to develop diagnostics, personalized medicines

Aug. 12, 2021
By Tamra Sami
PERTH, Australia – Bioinformatic and cell technology company Genieus Genomics Ltd. is using the power of the human genome to build a platform for neurodegenerative diseases to develop diagnostic tests for personalized medicines.
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Spintech’s MRI enhancement technology gets FDA nod

Aug. 10, 2021
By Meg Bryant
The FDA has given the green light to Spintech Inc. for its STAGE (strategically acquired gradient echo) magnetic resonance imaging device. The post-processing software platform allows MRI technicians to capture higher-quality brain images in significantly less time than standard approaches.
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Clinician accessing Biovitalshf dashboard on computer

FDA grants breakthrough status to Biofourmis’ digital therapy for heart failure

July 29, 2021
By Meg Bryant
Biofourmis Inc. won a breakthrough devices nod from the FDA for its Biovitalshf solution, a digital therapeutic for patients with heart failure with reduced ejection fraction (HFrEF). The company, which is pursuing the de novo pathway for the therapy, plans to launch a pivotal trial next month. Biovitalshf is intended to augment guideline-directed use of heart failure medications to manage patients in combination with traditional pharmacotherapy. The software application integrates physiological monitoring, symptoms and signs reporting, patient engagement, medication management and communications to provide clinicians with personalized and specific recommendations about their medication.
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Laptop displaying Peekmed software

Peek raises $3.5M for its AI-leveraged pre-op planning software for orthopedic surgery

July 29, 2021
By Bernard Banga
PARIS – Peek Health SA raised $3.5 million in series A funding to ramp development of its 3D pre-op digital planning tools used in orthopedic surgery. This investment was led by two Portuguese venture capital firms: Grosvenor House of Investments SCR SA and Portugal Ventures SA.
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3D illustration of knee joint

Rsip Vision releases technology for sports medicine and robotic assisted surgery

July 28, 2021
By David Ho
Rsip Vision Ltd. has maintained its momentum with a couple of new software module releases, one focused on sports medicine and another for robotic assisted surgery. The most recent release is a software module that enables deep learning-based segmentation of joint cartilage from MRI scans of hips, knees and ankles. “It's about using AI-based auto segmentation to provide clinically valuable measurements,” Moshe Safran, the CEO of Rsip Vision U.S., told BioWorld.
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