FDA approvals, funding and Helen HeadHunts Again

Coincidence or are the FDA secretly supporting October's not-so catchily titled 'Medical Ultrasound Awareness Month' (MUAM)? They've been busy boys and girls of late with lots of approvals to try and keep track of so let's dive into them.

Thy-roid on Time

PIUR IMAGING GmbH and See-Mode Technologies both shared timely FDA clearances of their respective Ultrasound thyroid products. See-Mode's solution is software-based and aims to to 'reduce reporting time and variation in delivery of care' whereas PIUR have both hardware and software components.

The takeaway marketing messages:

See-Mode: This is the first FDA-cleared product for both detection and diagnosis (CADe/x) of thyroid ultrasound.

PIUR: The PIUR tUS Infinity is the world’s first standalone ultrasound enhancement system capable of upgrading nearly any 2D ultrasound device to capture comprehensive 3D images.

iCardio cooking

iCardio have added an FDA cherry on top of their partner-thick icing in the making of a very tasty 2024 cake. Big name partnerships with 雅培 and Viz.ai have preceded the new FDA approval of their echocardiography interpretation technology.

Robert keeps Rohlin', Rohlin', Rohlin'

A good month if you're Robert Rohling , co-founder of both Sonus Microsystems and Sonic Incytes Medical Corp. Both shared promising updates over the last month. Whilst not yet FDA approved yet, Sonus have shared promising results for their polymer MEMS transducers for echocardiography vs. traditional PZT phased-array probes. Back up, back up, tell me what ya gonna do ????????? next Robert?

FLASH... Ah-Ha!

Sonic Incytes Medical Corp. meanwhile have secured 510(k) clearance for its Velacur? Determined Fat Fraction (VDFF) software which will be available in a Flash on all of their devices. Headed by Barry Allen , unofficial Saviour of the Universe. If you're thinking it sounds similar to what ENDRA Life Sciences (Nasdaq: NDRA) have been aiming to do then you're right, more news on them later...

Funding Fun

French start-up AdEchoTech successfully raised €4m which will be used for commercial expansion. Rather than utilising AI to address the lack of echo technicians, they've created a robotized tele-echography solution. They brought on three new investors in this round, a promising sign for future funding.

A Making Waves debut for Sonavex , off the back of their $2m grant which will be used to fund clinical trials and regulatory clearance for their EchoGuide product which is designed to reduce cannulation injury. As well as EchoGuide, they also have EchoMark, a bioresorbable and visible under ultrasound implant and EchoSure a device to be used by healthcare providers without ultrasound training to assess blood flow and morphology of vessels marked by the implanted EchoMark device.

Helen HeadHunts... Again

She's back and making moves in the world of Ultrasound:

?? Echo IQ (ASX:EIQ) who I included in the last edition, have appointed a new CEO dust in time to take advantage of the FDA approval of their EchoSolv AS software. Dustin Haines takes charge and will be charged with building on discussions with hospital groups, device manufacturers, and pharmaceutical companies in US and Europe.

?? Scott Peairs , VP Sales and David Cernicek RVT,RDMS , as VP Operations will be spearheading PIUR IMAGING GmbH 's US expansion. With my recruiter hat on, good to see sales alongside operations/clinical support. Having just one salesperson in the US is a sure fire way to make slow progress.

?? ENDRA Life Sciences (Nasdaq: NDRA) have announced wholesale changes to their leadership team to coincide with them changing tact to focusing on clinical trials and FDA approval. Board member Alexander Tokman steps in as interim CEO, alongside Richard Jacroux as CFO and Ziad R. as VP Regulatory and Clinical Affairs.

Neither Helen nor I were responsible for any of these hires but they're indicative of the types of roles I work on. Let me know if you're looking for assistance with hiring.

??Additional Reading??

Back in July's addition I posed the question who could tell us more about Ultromics and got my answer. This time around I've been wondering who can tell us more about Reimbursement for AI in Echo and the answer is the same...

Check out Ultromics ' CEO Ross Upton, PhD 's latest Substack on the reimbursement landscape and process.

???? RSNA 2024

I'll be heading to the windy city in December and interested in meeting familiar and not so familiar faces across the week. Get in touch should you want to meet.

??About Me??

I specialise in global medical imaging recruitment but have a passion for Ultrasound in particular. Within Ultrasound I have placed over 50 candidates with more than 15 different clients across North America, Europe and APAC. If you would like to discuss industry news, trends, gossip or recruitment please feel free to reach out.